Trial Outcomes & Findings for A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD) (NCT NCT04630145)
NCT ID: NCT04630145
Last Updated: 2026-04-15
Results Overview
Number of participants with sputum culture conversion in MGIT at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
129 participants
Primary outcome timeframe
At Week 24
Results posted on
2026-04-15
Participant Flow
Results are currently reported until the Week 24 cut-off. Results of remaining duration will be posted upon study completion.
Participant milestones
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
59
|
63
|
Reasons for withdrawal
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Baseline characteristics by cohort
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=64 Participants
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=65 Participants
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 11.4 • n=193 Participants
|
64.6 years
STANDARD_DEVIATION 9.34 • n=193 Participants
|
63.4 years
STANDARD_DEVIATION 10.45 • n=386 Participants
|
|
Age, Customized
59 years and under
|
23 Participants
n=193 Participants
|
21 Participants
n=193 Participants
|
44 Participants
n=386 Participants
|
|
Age, Customized
60 to 69 years
|
23 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
41 Participants
n=386 Participants
|
|
Age, Customized
70 years and over
|
18 Participants
n=193 Participants
|
26 Participants
n=193 Participants
|
44 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=193 Participants
|
52 Participants
n=193 Participants
|
106 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
23 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=193 Participants
|
65 Participants
n=193 Participants
|
129 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
64 Participants
n=193 Participants
|
65 Participants
n=193 Participants
|
129 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
JAPAN
|
59 Participants
n=193 Participants
|
59 Participants
n=193 Participants
|
118 Participants
n=386 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
3 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Region of Enrollment
TAIWAN
|
2 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: Intent to treat (ITT) analysis set included all randomized participants who were randomly assigned to an intervention arm and who took at least 1 dose of study intervention.
Number of participants with sputum culture conversion in MGIT at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart.
Outcome measures
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=64 Participants
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=65 Participants
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24
|
3 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At week 24Population: Intent to treat (ITT) analysis set included all randomized participants who were randomly assigned to an intervention arm and who took at least 1 dose of study intervention.
Number of participants with sputum culture conversion in 7H11 agar media at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart based on actual collection dates.
Outcome measures
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=64 Participants
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=65 Participants
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24
|
3 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: Intent to treat (ITT) analysis set included all randomized participants who were randomly assigned to an intervention arm and who took at least 1 dose of study intervention. Here, N (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The composite total score is derived from the 3 domain scores. Each domain score and the total score has a range of 0 to 100, with 0 indicating the best possible quality of life. An increase in score indicates worsening health.
Outcome measures
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=59 Participants
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=63 Participants
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24
|
-0.2 Score on scale
Standard Deviation 8.10
|
-3.8 Score on scale
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: At Week 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 2 to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 2 to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Day 1) up to Week 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Day 1) up to Week 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48 and Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: Intent to treat (ITT) analysis set included all randomized participants who were randomly assigned to an intervention arm and who took at least 1 dose of study intervention. Here, N (overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies participants evaluated for specified categories.
Change from baseline in lung function parameters (Forced expiratory volume in one second, Forced vital capacity, Inspiratory capacity, Functional residual capacity, Total lung capacity) at Week 24 was reported.
Outcome measures
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=58 Participants
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=63 Participants
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Change From Baseline in Lung Function Parameters at Week 24
Functional residual capacity
|
15.5 milliliters
Standard Deviation 330.42
|
26.8 milliliters
Standard Deviation 271.52
|
|
Change From Baseline in Lung Function Parameters at Week 24
Forced expiratory volume in one second
|
-6.9 milliliters
Standard Deviation 83.36
|
-14.3 milliliters
Standard Deviation 123.26
|
|
Change From Baseline in Lung Function Parameters at Week 24
Forced vital capacity
|
0.7 milliliters
Standard Deviation 103.99
|
-16.0 milliliters
Standard Deviation 209.99
|
|
Change From Baseline in Lung Function Parameters at Week 24
Inspiratory capacity
|
-7.8 milliliters
Standard Deviation 212.55
|
-37.7 milliliters
Standard Deviation 178.86
|
|
Change From Baseline in Lung Function Parameters at Week 24
Total lung capacity
|
11.7 milliliters
Standard Deviation 336.36
|
-1.6 milliliters
Standard Deviation 302.86
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48 and Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 24Population: Intent to treat (ITT) analysis set included all randomized participants who were randomly assigned to an intervention arm and who took at least 1 dose of study intervention.
Percentage of participants who underwent a change in their Mycobacterium avium Complex-lung disease (MAC-LD) treatment regimen by Week 24 was reported.
Outcome measures
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=64 Participants
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=65 Participants
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24
|
1.6 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48 and Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 60Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Weeks 2, 8, 12, 24 and Week 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Weeks 2, 8, 12 and 24Outcome measures
Outcome data not reported
Adverse Events
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=64 participants at risk
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=65 participants at risk
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
1/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Covid-19
|
0.00%
0/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
1.5%
1/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
1.5%
1/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
1.5%
1/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.6%
1/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
1.5%
1/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
Other adverse events
| Measure |
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
n=64 participants at risk
Participants received rifamycin (either rifampicin \[RFP\] 450 milligrams \[mg\] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin \[RBT\] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60.
|
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
n=65 participants at risk
Participants received BDQ 400 mg (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48.
|
|---|---|---|
|
General disorders
Pyrexia
|
3.1%
2/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
7.7%
5/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Covid-19
|
9.4%
6/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
9.2%
6/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
3/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
6.2%
4/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
6.2%
4/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
4.6%
3/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
4/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
9.2%
6/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Dysgeusia
|
3.1%
2/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
7.7%
5/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Headache
|
6.2%
4/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
10.8%
7/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
9.2%
6/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
2/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
6.2%
4/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
5/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
7.7%
5/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
3/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
18.5%
12/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
3/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
7.7%
5/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
4/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Malaise
|
3.1%
2/64 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
7.7%
5/65 • All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
|
Additional Information
Global Medical Head Mycobacteria
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER