Trial · NCT02015637
Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
NCT02015637, Phase 3, Terminated, Melinta Therapeutics, Inc.; results first posted 2018-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea. Trials, record NCT02015637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02015637
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
- NCT number
- NCT02015637
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Melinta Therapeutics, Inc.
- Conditions
- Gonorrhea
- Interventions
- Delafloxacin, Ceftriaxone
- First posted
- 2013-12-19
- Last updated
- 2018-06-20
- Results first posted
- 2018-04-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Day 7 (± 3 days) | 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. |
| Secondary | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Day 7 (± 3 days) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Day 7 (± 3 days) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Day 7 (± 3 days) | 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 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Delafloxacin | Cure | 194 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Ceftriaxone | Cure | 91 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Delafloxacin | Failure | 34 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population | Ceftriaxone | Failure | 9 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Delafloxacin | Cure | 194 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Ceftriaxone | Cure | 91 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Delafloxacin | Failure | 32 | Participants | |
| Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population | Ceftriaxone | Failure | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Delafloxacin | 306 | |
| Overall Study | STARTED | Ceftriaxone | 154 | |
| Overall Study | COMPLETED | Delafloxacin | 298 | |
| Overall Study | COMPLETED | Ceftriaxone | 149 | |
| Overall Study | NOT COMPLETED | Delafloxacin | 8 | |
| Overall Study | NOT COMPLETED | Ceftriaxone | 5 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Delafloxacin | 97 | 304 | |
| other | Diarrhea | Gastrointestinal disorders | Ceftriaxone | 11 | 154 | |
| other | Nausea | Gastrointestinal disorders | Delafloxacin | 24 | 304 | |
| other | Nausea | Gastrointestinal disorders | Ceftriaxone | 2 | 154 | |
| serious | Ankle fracture | Musculoskeletal and connective tissue disorders | Delafloxacin | 0 | 304 | |
| serious | Ankle fracture | Musculoskeletal and connective tissue disorders | Ceftriaxone | 1 | 154 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delafloxacin | 0 | 304 |
| Total, all-cause mortality | Ceftriaxone | 0 | 154 |
| Total, other adverse events | Delafloxacin | 121 | 304 |
| Total, other adverse events | Ceftriaxone | 13 | 154 |
| Total, serious adverse events | Delafloxacin | 0 | 304 |
| Total, serious adverse events | Ceftriaxone | 1 | 154 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30985632 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Delafloxacin vs Ceftriaxone: deaths from any cause | Trial comparisons |
| Delafloxacin vs Ceftriaxone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02015637
GET https://conductscience.org/api/trials/v1/NCT02015637/registered