Trial · NCT04010539
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
NCT04010539, Phase 3, Completed, GlaxoSmithKline; results first posted 2024-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea. Trials, record NCT04010539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04010539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
- NCT number
- NCT04010539
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 628 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gonorrhea
- Interventions
- Gepotidacin, Ceftriaxone, Azithromycin
- First posted
- 2019-07-08
- Last updated
- 2024-05-30
- Other registries' IDs
- eudract:2018-001780-23
- Results first posted
- 2024-05-30
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit. |
| Secondary | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Rectal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit. |
| Secondary | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Pharyngeal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Up to 21 days | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. |
| Secondary | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Secondary | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Microbiological intent-to-treat (Micro-ITT) population included all participants randomly assigned to study treatment who received at least 1 dose of study treatment and have confirmed NG isolated that is ceftriaxone-susceptible (based on CLSI breakpoints) from baseline culture of their urogenital specimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Micro-ITT Rectal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their rectal specimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Micro-ITT Pharyngeal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their pharyngeal specimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Up to 21 days | Safety population included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Giga cells per liter (10^9 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Percentage | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Trillion cells per liter (10^12 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Picograms (pg) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Safety population. Only those participants with data available at specified time points have been analyzed. | Femtoliters (fL) | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group218
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Gepotidacin | Microbiological success | 187 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Ceftriaxone Plus Azithromycin | Microbiological success | 186 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Gepotidacin | Microbiological failure, BP | 0 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Ceftriaxone Plus Azithromycin | Microbiological failure, BP | 0 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Gepotidacin | Microbiological failure, UTD | 15 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Ceftriaxone Plus Azithromycin | Microbiological failure, UTD | 18 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Gepotidacin | Microbiological success | 26 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Ceftriaxone Plus Azithromycin | Microbiological success | 12 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Gepotidacin | Microbiological failure, BP | 0 | Participants | |
| Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Ceftriaxone Plus Azithromycin | Microbiological failure, BP | 0 | Participants |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gepotidacin | 314 | |
| Overall Study | STARTED | Ceftriaxone Plus Azithromycin | 314 | |
| Overall Study | Safety Population | Gepotidacin | 309 | |
| Overall Study | Safety Population | Ceftriaxone Plus Azithromycin | 313 | |
| Overall Study | Microbiological ITT (Micro-ITT) Population | Gepotidacin | 202 | |
| Overall Study | Microbiological ITT (Micro-ITT) Population | Ceftriaxone Plus Azithromycin | 204 | |
| Overall Study | Micro-ITT Rectal Population | Gepotidacin | 26 | |
| Overall Study | Micro-ITT Rectal Population | Ceftriaxone Plus Azithromycin | 15 | |
| Overall Study | Micro-ITT Pharyngeal Population | Gepotidacin | 18 | |
| Overall Study | Micro-ITT Pharyngeal Population | Ceftriaxone Plus Azithromycin | 17 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events40
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 | Diarrhoea | Gastrointestinal disorders | Gepotidacin | 151 | 309 | 167 |
| other | Diarrhoea | Gastrointestinal disorders | Ceftriaxone Plus Azithromycin | 30 | 313 | 30 |
| other | Nausea | Gastrointestinal disorders | Gepotidacin | 73 | 309 | 80 |
| other | Nausea | Gastrointestinal disorders | Ceftriaxone Plus Azithromycin | 9 | 313 | 9 |
| other | Vomiting | Gastrointestinal disorders | Gepotidacin | 20 | 309 | 21 |
| other | Vomiting | Gastrointestinal disorders | Ceftriaxone Plus Azithromycin | 2 | 313 | 2 |
| other | Flatulence | Gastrointestinal disorders | Gepotidacin | 20 | 309 | 20 |
| other | Flatulence | Gastrointestinal disorders | Ceftriaxone Plus Azithromycin | 1 | 313 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Gepotidacin | 16 | 309 | 17 |
| other | Abdominal Pain | Gastrointestinal disorders | Ceftriaxone Plus Azithromycin | 3 | 313 | 4 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gepotidacin | 0 | 309 |
| Total, all-cause mortality | Ceftriaxone Plus Azithromycin | 0 | 313 |
| Total, other adverse events | Gepotidacin | 230 | 309 |
| Total, other adverse events | Ceftriaxone Plus Azithromycin | 81 | 313 |
| Total, serious adverse events | Gepotidacin | 1 | 309 |
| Total, serious adverse events | Ceftriaxone Plus Azithromycin | 0 | 313 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Gepotidacin vs Ceftriaxone Plus Azithromycin: deaths from any cause | Trial comparisons |
| Gepotidacin vs Ceftriaxone Plus Azithromycin: 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/NCT04010539
GET https://conductscience.org/api/trials/v1/NCT04010539/results?page=2