Trial Outcomes & Findings for Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea (NCT NCT02015637)
NCT ID: NCT02015637
Last Updated: 2018-06-20
Results Overview
Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
460 participants
Primary outcome timeframe
Day 7 (± 3 days)
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
Delafloxacin
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
154
|
|
Overall Study
COMPLETED
|
298
|
149
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Delafloxacin
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Did not take study drug
|
2
|
0
|
Baseline Characteristics
This information was collected on males only.
Baseline characteristics by cohort
| Measure |
Delafloxacin
n=304 Participants
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
n=154 Participants
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 8.82 • n=304 Participants
|
28.7 years
STANDARD_DEVIATION 10.04 • n=154 Participants
|
29.3 years
STANDARD_DEVIATION 9.25 • n=458 Participants
|
|
Age, Customized
<18 year
|
1 Participants
n=304 Participants
|
2 Participants
n=154 Participants
|
3 Participants
n=458 Participants
|
|
Age, Customized
18-70 years
|
303 Participants
n=304 Participants
|
152 Participants
n=154 Participants
|
455 Participants
n=458 Participants
|
|
Sex/Gender, Customized
Men who: · Were heterosexul
|
132 Participants
n=245 Participants • This information was collected on males only.
|
59 Participants
n=119 Participants • This information was collected on males only.
|
191 Participants
n=364 Participants • This information was collected on males only.
|
|
Sex/Gender, Customized
Men who: · Had sex with men or were bisexual
|
112 Participants
n=245 Participants • This information was collected on males only.
|
60 Participants
n=119 Participants • This information was collected on males only.
|
172 Participants
n=364 Participants • This information was collected on males only.
|
|
Sex/Gender, Customized
Men who: · Missing
|
1 Participants
n=245 Participants • This information was collected on males only.
|
0 Participants
n=119 Participants • This information was collected on males only.
|
1 Participants
n=364 Participants • This information was collected on males only.
|
|
Sex: Female, Male
Female
|
59 Participants
n=304 Participants
|
35 Participants
n=154 Participants
|
94 Participants
n=458 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=304 Participants
|
119 Participants
n=154 Participants
|
364 Participants
n=458 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=304 Participants
|
22 Participants
n=154 Participants
|
56 Participants
n=458 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
268 Participants
n=304 Participants
|
131 Participants
n=154 Participants
|
399 Participants
n=458 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=304 Participants
|
1 Participants
n=154 Participants
|
3 Participants
n=458 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=304 Participants
|
0 Participants
n=154 Participants
|
1 Participants
n=458 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=304 Participants
|
1 Participants
n=154 Participants
|
8 Participants
n=458 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=304 Participants
|
0 Participants
n=154 Participants
|
0 Participants
n=458 Participants
|
|
Race (NIH/OMB)
Black or African American
|
186 Participants
n=304 Participants
|
92 Participants
n=154 Participants
|
278 Participants
n=458 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=304 Participants
|
48 Participants
n=154 Participants
|
146 Participants
n=458 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=304 Participants
|
0 Participants
n=154 Participants
|
0 Participants
n=458 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=304 Participants
|
13 Participants
n=154 Participants
|
25 Participants
n=458 Participants
|
|
Positive culture for Gonorrhea (GC)
|
239 Participants
n=304 Participants
|
107 Participants
n=154 Participants
|
346 Participants
n=458 Participants
|
PRIMARY outcome
Timeframe: Day 7 (± 3 days)Population: The primary efficacy analysis was done on the UMITT population, which included all subjects in the ITT analysis set who had a positive culture for N gonorrhoeae obtained at a urogenital site at the Entry Visit, and who did not receive antibiotic therapy for a C trachomatis infection that was potentially effective against N gonorrhoeae prior to TOC.
Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Outcome measures
| Measure |
Delafloxacin
n=228 Participants
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
n=100 Participants
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
|---|---|---|
|
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
Cure
|
194 Participants
|
91 Participants
|
|
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
Failure
|
34 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 7 (± 3 days)Population: Urogenital ME (UME): All subjects included in the UMITT analysis set who received study drug and had no important protocol deviations that would affect the assessment of efficacy
Cure for the seconday outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Outcome measures
| Measure |
Delafloxacin
n=226 Participants
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
n=95 Participants
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
|---|---|---|
|
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
Cure
|
194 Participants
|
91 Participants
|
|
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
Failure
|
32 Participants
|
4 Participants
|
Adverse Events
Delafloxacin
Serious events: 0 serious events
Other events: 121 other events
Deaths: 0 deaths
Ceftriaxone
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Delafloxacin
n=304 participants at risk
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
n=154 participants at risk
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/304 • All Adverse Events (AEs) occurring from the time the subject signed the Informed Consent Form (ICF) through the follow-up phone contact were reported and followed to resolution. Collection of all AEs occurred from the time the subject received study drug (Day 1) through the TOC visit (Day 7 +/- 3), or up to 10 days. Only Serious Adverse Events (SAEs) were collected after the TOC visit through the follow-up phone contact (Day 30 +/- 3 days), or up to 33 days.
AEs were reported in the Safety Population which was defined as all subjects that received study drug. Two patients that were in the ITT population (all subjects randomly assigned to a treatment group) for delafloxacin did not receive study drug.
|
0.65%
1/154 • All Adverse Events (AEs) occurring from the time the subject signed the Informed Consent Form (ICF) through the follow-up phone contact were reported and followed to resolution. Collection of all AEs occurred from the time the subject received study drug (Day 1) through the TOC visit (Day 7 +/- 3), or up to 10 days. Only Serious Adverse Events (SAEs) were collected after the TOC visit through the follow-up phone contact (Day 30 +/- 3 days), or up to 33 days.
AEs were reported in the Safety Population which was defined as all subjects that received study drug. Two patients that were in the ITT population (all subjects randomly assigned to a treatment group) for delafloxacin did not receive study drug.
|
Other adverse events
| Measure |
Delafloxacin
n=304 participants at risk
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin: single dose
|
Ceftriaxone
n=154 participants at risk
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone: single dose
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
31.9%
97/304 • All Adverse Events (AEs) occurring from the time the subject signed the Informed Consent Form (ICF) through the follow-up phone contact were reported and followed to resolution. Collection of all AEs occurred from the time the subject received study drug (Day 1) through the TOC visit (Day 7 +/- 3), or up to 10 days. Only Serious Adverse Events (SAEs) were collected after the TOC visit through the follow-up phone contact (Day 30 +/- 3 days), or up to 33 days.
AEs were reported in the Safety Population which was defined as all subjects that received study drug. Two patients that were in the ITT population (all subjects randomly assigned to a treatment group) for delafloxacin did not receive study drug.
|
7.1%
11/154 • All Adverse Events (AEs) occurring from the time the subject signed the Informed Consent Form (ICF) through the follow-up phone contact were reported and followed to resolution. Collection of all AEs occurred from the time the subject received study drug (Day 1) through the TOC visit (Day 7 +/- 3), or up to 10 days. Only Serious Adverse Events (SAEs) were collected after the TOC visit through the follow-up phone contact (Day 30 +/- 3 days), or up to 33 days.
AEs were reported in the Safety Population which was defined as all subjects that received study drug. Two patients that were in the ITT population (all subjects randomly assigned to a treatment group) for delafloxacin did not receive study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
24/304 • All Adverse Events (AEs) occurring from the time the subject signed the Informed Consent Form (ICF) through the follow-up phone contact were reported and followed to resolution. Collection of all AEs occurred from the time the subject received study drug (Day 1) through the TOC visit (Day 7 +/- 3), or up to 10 days. Only Serious Adverse Events (SAEs) were collected after the TOC visit through the follow-up phone contact (Day 30 +/- 3 days), or up to 33 days.
AEs were reported in the Safety Population which was defined as all subjects that received study drug. Two patients that were in the ITT population (all subjects randomly assigned to a treatment group) for delafloxacin did not receive study drug.
|
1.3%
2/154 • All Adverse Events (AEs) occurring from the time the subject signed the Informed Consent Form (ICF) through the follow-up phone contact were reported and followed to resolution. Collection of all AEs occurred from the time the subject received study drug (Day 1) through the TOC visit (Day 7 +/- 3), or up to 10 days. Only Serious Adverse Events (SAEs) were collected after the TOC visit through the follow-up phone contact (Day 30 +/- 3 days), or up to 33 days.
AEs were reported in the Safety Population which was defined as all subjects that received study drug. Two patients that were in the ITT population (all subjects randomly assigned to a treatment group) for delafloxacin did not receive study drug.
|
Additional Information
Susan K. Cammarata, M.D. (Chief Medical Officer)
Melinta Therapeutics, Inc.
Phone: 1-844-MELINTA (1-844-635-4682)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Melinta has the right to first publication of results, which would be made in conjunction with the PIs from all appropriate sites. Thereafter, PIs may publish results provided the PI submits the proposed publication to Melinta for review at least 60 days prior to the date of the proposed publication. Melinta may remove any information that is considered confidential and/or proprietary. If a publication is not submitted within 12 months of study conclusion, the PI may publish results.
- Publication restrictions are in place
Restriction type: OTHER