Trial Outcomes & Findings for PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE) (NCT NCT04550832)
NCT ID: NCT04550832
Last Updated: 2025-09-16
Results Overview
Participants with ≥ 1 TEAE, by severity, related Adverse events: possibly, probably, or definitely related to study drugs
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
week0 - week52
Results posted on
2025-09-16
Participant Flow
This study was initiated on 28 October 2021 (first signed informed consent) with the date of last participant who completed last study visit on 04 Sep 2023. A total of 156 participants were screened. Of these, 76 participants were randomized to 1 of 5 arms, and subsequently received at least 1 dose of the study drug. The remaining 80 participants were considered to have been screen failures.
Participant milestones
| Measure |
Arm1(D0)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquilin was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
16
|
15
|
|
Overall Study
Received ≥ 1 Dose of Study Drug
|
15
|
15
|
15
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
13
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm1(D0)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquilin was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
Participants received the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
1
|
Baseline Characteristics
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
Baseline characteristics by cohort
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was be dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was be dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was be dosed 1200 mg orally once daily
* Bedaquiline was be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was be dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was be dosed 800 mg orally twice daily
* Bedaquiline was be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was be dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
39.7 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
35.1 years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
34.1 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 8.4 • n=31 Participants
|
35.5 years
STANDARD_DEVIATION 9.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
60 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
74 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
76 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Body Mass Index (BMI)
|
18.2 kg/m2
STANDARD_DEVIATION 1.8 • n=99 Participants
|
18.8 kg/m2
STANDARD_DEVIATION 2.1 • n=107 Participants
|
20.0 kg/m2
STANDARD_DEVIATION 3.8 • n=206 Participants
|
20.2 kg/m2
STANDARD_DEVIATION 3.0 • n=7 Participants
|
20.0 kg/m2
STANDARD_DEVIATION 3.5 • n=31 Participants
|
19.5 kg/m2
STANDARD_DEVIATION 3.0 • n=30 Participants
|
|
HIV status
Negative
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
65 Participants
n=30 Participants
|
|
HIV status
Positive
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
|
GeneXpert CT results
< 16 ; high bacili (TB) load
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
GeneXpert CT results
≥ 16 ; low bacili (TB) load
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
61 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: week0 - week52Population: Safety Population
Participants with ≥ 1 TEAE, by severity, related Adverse events: possibly, probably, or definitely related to study drugs
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
SAE-Grade 4 (life-threatening)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
DZD-unrelated SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
DZD-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
TEAE (total)
|
8 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Grade 1 (mild)
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Grade 2 (moderate)
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Grade 3 (severe)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Grade 4 (life-threatening)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Unrelated
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Unlikely related
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Possibly related
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Probably related
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
Definitely related
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Outcome : Proportion of Patients Experiencing Adverse Event
SAE- Grade 3 (severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_AUC0-24
|
NA mg/L*h
Delpazolid is not administered in this arm.
|
10.1 mg/L*h
Interval 6.86 to 20.4
|
28.6 mg/L*h
Interval 15.1 to 76.7
|
47.0 mg/L*h
Interval 11.8 to 94.0
|
68.5 mg/L*h
Interval 28.8 to 198.0
|
PRIMARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmax
|
NA mg/L
Delpazolid is not administered in this arm.
|
3.78 mg/L
Interval 2.92 to 4.45
|
7.72 mg/L
Interval 5.78 to 13.9
|
13.7 mg/L
Interval 9.56 to 19.7
|
9.16 mg/L
Interval 7.56 to 13.4
|
PRIMARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmin
|
NA mg/L
Delpazolid is not administered in this arm.
|
0.00296 mg/L
Interval 0.000437 to 0.459
|
0.00948 mg/L
Interval 0.000439 to 0.81
|
0.00240 mg/L
Interval 0.000215 to 0.291
|
0.00400 mg/L
Interval 0.000157 to 0.564
|
SECONDARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
Summary of Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media - Intent to Treat Population Sputum samples were collected for BD MGIT960® Liquid Media culture at all time points during the treatment and follow-up phases, and this table shows culture results, which are reported as: Positive, Negative, Contaminated, Missing. Note: Contaminated cultures are shown as contaminated for the purpose of the overall result but are counted as missing for calculating summary statistics. The data recorded as 'Positive for MTB Complex with Contamination' are included as 'Positive' for MGIT result. However, the data from mean and median calculations for TTP (Time to positive) due to contamination.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 0 · Positive
|
15 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 0 · Negative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 0 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 0 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 1 · Positive
|
15 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 1 · Negative
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 1 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 1 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 2 · Positive
|
15 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
15 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 2 · Negative
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 2 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 2 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 3 · Positive
|
15 Participants
|
13 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 3 · Negative
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 3 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 3 · Missing
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 4 · Positive
|
13 Participants
|
13 Participants
|
13 Participants
|
14 Participants
|
12 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 4 · Negative
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 4 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 4 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 5 · Positive
|
14 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
12 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 5 · Negative
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 5 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 5 · Missing
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 6 · Positive
|
9 Participants
|
9 Participants
|
12 Participants
|
10 Participants
|
12 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 6 · Negative
|
5 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 6 · Contaminated
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 6 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 7 · Positive
|
9 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 7 · Negative
|
6 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 7 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 7 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 8 · Positive
|
6 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 8 · Negative
|
9 Participants
|
9 Participants
|
9 Participants
|
13 Participants
|
7 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 8 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 8 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 9 · Positive
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 9 · Negative
|
10 Participants
|
11 Participants
|
11 Participants
|
13 Participants
|
11 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 9 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 9 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 10 · Positive
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 10 · Negative
|
10 Participants
|
12 Participants
|
12 Participants
|
13 Participants
|
11 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 10 · Contaminated
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 10 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 11 · Positive
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 11 · Negative
|
11 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 11 · Contaminated
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 11 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 12 · Positive
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 12 · Negative
|
12 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
13 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 12 · Contaminated
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 12 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 13 · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 13 · Negative
|
15 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 13 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 13 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 14 · Positive
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 14 · Negative
|
13 Participants
|
15 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 14 · Contaminated
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 14 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 15 · Positive
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 15 · Negative
|
14 Participants
|
15 Participants
|
13 Participants
|
16 Participants
|
14 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 15 · Contaminated
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 15 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 16 · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 16 · Negative
|
14 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 16 · Contaminated
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Week 16 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by time to positivity (TTP) in BD MGIT 960® liquid culture described by nonlinear mixed-effects methodology. Sputum samples were collected for BD MGIT960® Liquid Media culture at all time points during the treatment and follow-up phases, and this table shows TTP results.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 1
|
10.9 days
Standard Deviation 3.2
|
13.0 days
Standard Deviation 8.9
|
10.1 days
Standard Deviation 3.8
|
11.1 days
Standard Deviation 8.8
|
9.6 days
Standard Deviation 3.3
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 2
|
13.3 days
Standard Deviation 4.3
|
16.9 days
Standard Deviation 9.9
|
15.4 days
Standard Deviation 8.6
|
13.7 days
Standard Deviation 7.8
|
12.2 days
Standard Deviation 3.7
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 3
|
16.6 days
Standard Deviation 6.5
|
18.0 days
Standard Deviation 11.8
|
16.0 days
Standard Deviation 8.4
|
14.2 days
Standard Deviation 6.4
|
15.7 days
Standard Deviation 8.2
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 4
|
19.1 days
Standard Deviation 10.4
|
18.3 days
Standard Deviation 10.3
|
18.7 days
Standard Deviation 8.1
|
21.2 days
Standard Deviation 10.1
|
19.8 days
Standard Deviation 12.1
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 5
|
23.6 days
Standard Deviation 9.2
|
24.4 days
Standard Deviation 11.0
|
23.3 days
Standard Deviation 10.1
|
25.3 days
Standard Deviation 10.4
|
23.8 days
Standard Deviation 10.8
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 6
|
27.3 days
Standard Deviation 11.9
|
29.7 days
Standard Deviation 11.4
|
2.74 days
Standard Deviation 8.4
|
27.9 days
Standard Deviation 12.1
|
26.9 days
Standard Deviation 10.3
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 7
|
30.8 days
Standard Deviation 11.7
|
31.6 days
Standard Deviation 10.9
|
35.1 days
Standard Deviation 9.7
|
33.6 days
Standard Deviation 10.9
|
30.9 days
Standard Deviation 12.5
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 8
|
33.3 days
Standard Deviation 12.0
|
36.6 days
Standard Deviation 8.9
|
36.3 days
Standard Deviation 9.7
|
39.4 days
Standard Deviation 7.5
|
33.2 days
Standard Deviation 11.1
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 9
|
35.8 days
Standard Deviation 10.3
|
37.7 days
Standard Deviation 9.7
|
38.0 days
Standard Deviation 8.3
|
37.0 days
Standard Deviation 10.9
|
38.8 days
Standard Deviation 7.8
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 10
|
36.4 days
Standard Deviation 10.1
|
37.8 days
Standard Deviation 9.1
|
40.5 days
Standard Deviation 5.4
|
39.3 days
Standard Deviation 7.3
|
39.7 days
Standard Deviation 5.5
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 11
|
36.6 days
Standard Deviation 11.5
|
40.1 days
Standard Deviation 5.2
|
40.9 days
Standard Deviation 4.3
|
41.4 days
Standard Deviation 2.4
|
38.5 days
Standard Deviation 9.4
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 12
|
38.5 days
Standard Deviation 9.3
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
40.0 days
Standard Deviation 6.1
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 13
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
39.2 days
Standard Deviation 7.3
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 14
|
39.9 days
Standard Deviation 8.0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
39.4 days
Standard Deviation 7.8
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 15
|
39.7 days
Standard Deviation 8.9
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
40.0 days
Standard Deviation 7.8
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 16
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
42.0 days
Standard Deviation 0
|
40.0 days
Standard Deviation 7.7
|
|
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Week 0
|
5.6 days
Standard Deviation 2.2
|
6.5 days
Standard Deviation 4.1
|
7.2 days
Standard Deviation 5.7
|
8.0 days
Standard Deviation 9.0
|
5.9 days
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
Summary of Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Culture Conversion in Loewenstein-Jensen Solid Media - Intent-to-Treat Population Sputum samples were collected for Loewenstein-Jensen Solid Media culture at at Week 0, Week 8, Week 12, Week 6 during the treatment and follow-up phases, and this table shows culture results, which are reported as: Positive, Negative, Contaminated, Missing.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 0 · Positive
|
14 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 0 · Negative
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 0 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 0 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 8 · Positive
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 8 · Negative
|
11 Participants
|
12 Participants
|
11 Participants
|
15 Participants
|
12 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 8 · Contaminated
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 8 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 12 · Positive
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 12 · Negative
|
13 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 12 · Contaminated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 12 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 16 · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 16 · Negative
|
14 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 16 · Contaminated
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Week 16 · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
Culture conversion was defined as 2 negative cultures without an intervening positive culture. Time was measured as time on treatment until the first negative culture (up to Week 16 Visit). 'Converted by Week x' shows proportion converted by day corresponding to end of each week, e.g., Week 2 = Day 14.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 0
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 2
|
0 percentage of participants
|
6.7 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 3
|
0 percentage of participants
|
6.7 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 4
|
6.7 percentage of participants
|
6.7 percentage of participants
|
13.8 percentage of participants
|
6.2 percentage of participants
|
13.3 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 11
|
73.3 percentage of participants
|
86.7 percentage of participants
|
92.8 percentage of participants
|
93.8 percentage of participants
|
86.7 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 14
|
93.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
86.7 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 15
|
93.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
93.3 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 16
|
93.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
93.3 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 5
|
6.7 percentage of participants
|
20.0 percentage of participants
|
13.8 percentage of participants
|
18.8 percentage of participants
|
13.3 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 6
|
33.3 percentage of participants
|
40.0 percentage of participants
|
21.0 percentage of participants
|
37.5 percentage of participants
|
13.3 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 7
|
40.0 percentage of participants
|
46.7 percentage of participants
|
64.1 percentage of participants
|
43.8 percentage of participants
|
40.0 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 8
|
60.0 percentage of participants
|
73.3 percentage of participants
|
64.1 percentage of participants
|
75.0 percentage of participants
|
46.7 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 9
|
60.0 percentage of participants
|
86.7 percentage of participants
|
78.5 percentage of participants
|
87.5 percentage of participants
|
73.3 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 10
|
66.7 percentage of participants
|
86.7 percentage of participants
|
92.8 percentage of participants
|
87.5 percentage of participants
|
80.0 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 12
|
80.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
86.7 percentage of participants
|
|
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Week 13
|
93.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
86.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 16Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
Time to culture conversion was defined as 2 negative cultures without an intervening positive culture. Time was measured as time on treatment until the first negative culture (up to Week 16 Visit).
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome: Time to Culture Conversion
|
56.0 Days
Interval 42.0 to 84.0
|
56.0 Days
Interval 42.0 to 63.0
|
59.0 Days
Interval 49.0 to 63.0
|
56.0 Days
Interval 42.0 to 59.5
|
63.0 Days
Interval 49.0 to 70.0
|
SECONDARY outcome
Timeframe: Week0 - Week52Population: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.
A participant was positive for relapse or reinfection if they converted to culture negative by Week 8 and had 2 consecutive positive cultures after Week 16 of randomization, without an intervening negative.
Outcome measures
| Measure |
Arm1(D0)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was not administered
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm2(D400)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 400 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm3(D800-OD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm4(D1200)
n=16 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 1200 mg orally once daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
Arm5(D800-BD)
n=15 Participants
Participants receive the following medication for the duration of 16 weeks together with food.
* Delpazolid was dosed 800 mg orally twice daily
* Bedaquiline was dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week.
* Delamanid was dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg.
* Moxifloxacin was dosed as per the licensed dose: 400 mg orally once daily
Delpazolid: Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, Moxifloxacin: These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
|
|---|---|---|---|---|---|
|
Efficacy Outcome : Relapse or Reinfection
Conversion by Week 8 and positive culture past week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Efficacy Outcome : Relapse or Reinfection
Conversion by Week 8 and no positive culture past week 12
|
9 Participants
|
11 Participants
|
10 Participants
|
12 Participants
|
5 Participants
|
|
Efficacy Outcome : Relapse or Reinfection
Did not convert by Week 8
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
|
Efficacy Outcome : Relapse or Reinfection
Relapsed or reinfected
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Outcome : Relapse or Reinfection
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm1(D0)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm2(D400)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm3(D800-OD)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm4(D1200)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm5(D800-BD)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm1(D0)
n=15 participants at risk
BDM group
* Bedaquiline
* Delamanid
* Moxifloxacin
|
Arm2(D400)
n=15 participants at risk
BDM + delpazolid 400 mg QD group
|
Arm3(D800-OD)
n=15 participants at risk
BDM + delpazolid 800 mg QD group
|
Arm4(D1200)
n=16 participants at risk
BDM + delpazolid 1200 mg QD group
|
Arm5(D800-BD)
n=15 participants at risk
BDM + delpazolid 800 mg BID group
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
Other adverse events
| Measure |
Arm1(D0)
n=15 participants at risk
BDM group
* Bedaquiline
* Delamanid
* Moxifloxacin
|
Arm2(D400)
n=15 participants at risk
BDM + delpazolid 400 mg QD group
|
Arm3(D800-OD)
n=15 participants at risk
BDM + delpazolid 800 mg QD group
|
Arm4(D1200)
n=16 participants at risk
BDM + delpazolid 1200 mg QD group
|
Arm5(D800-BD)
n=15 participants at risk
BDM + delpazolid 800 mg BID group
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
20.0%
3/15 • Number of events 3 • From Week 0 to Week 52
|
12.5%
2/16 • Number of events 2 • From Week 0 to Week 52
|
26.7%
4/15 • Number of events 4 • From Week 0 to Week 52
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
12.5%
2/16 • Number of events 2 • From Week 0 to Week 52
|
20.0%
3/15 • Number of events 3 • From Week 0 to Week 52
|
|
General disorders
Pyrexia
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Investigations
Electrocardiogram QT prolonged
|
13.3%
2/15 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 3 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Investigations
Gamma glutamyl transferase increased
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 2 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 2 • From Week 0 to Week 52
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.2%
1/16 • Number of events 2 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
13.3%
2/15 • Number of events 3 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/15 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
6.7%
1/15 • Number of events 1 • From Week 0 to Week 52
|
0.00%
0/16 • From Week 0 to Week 52
|
0.00%
0/15 • From Week 0 to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place