Trial · NCT05630833
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
NCT05630833, Phase 3, Completed, GlaxoSmithKline; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis). Trials, record NCT05630833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05630833
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
- NCT number
- NCT05630833
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 380 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Urinary Tract Infections
- Interventions
- Gepotidacin, Nitrofurantoin, Placebo
- First posted
- 2022-11-30
- Last updated
- 2025-03-17
- Results first posted
- 2025-03-17
- Limitations and caveats
GlaxoSmithKline (GSK) was informed of suspected GCP violations in a Japanese site management organization which provided site management services to one of the sites for this study, at which 6 participants were enrolled (5 gepotidacin participants; 1 nitrofurantoin participant). These 6 participants were excluded from the analysis due to data integrity issues including undeniable suspected data falsification that resulted in unreliable data.
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Secondary | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Secondary | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met). |
| Secondary | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC. |
| Secondary | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC. |
| Secondary | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes. |
| Secondary | Number of Participants With Therapeutic Response (TR) at the TOC Visit | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Secondary | Number of Participants With Clinical Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met). |
| Secondary | Number of Participants With Clinical Response at the TOC Visit | At TOC visit (Days 9 to 16) | Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC. |
| Secondary | Number of Participants With Microbiological Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
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 Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S population. Participants in micro-ITT population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S). Additionally, for the statistical analysis, therapeutic success data from the pooled global studies 204989 (NCT04020341) and 212390 (NCT04187144) were used to derive the predictive distribution, to assess the consistency of gepotidacin's therapeutic success in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population. Participants in the micro-ITT Population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Therapeutic Response (TR) at the TOC Visit | At TOC visit (Days 9 to 16) | Microbiological intent-to-treat multi drug resistant (Micro-ITT MDR) population included all participants in the micro-ITT Population who had any qualifying baseline bacterial uropathogens that were resistant to two or more classes of antimicrobials. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group380
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 Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | Gepotidacin | Therapeutic Success | 69 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | Gepotidacin | Therapeutic Failure | 14 | Participants | |
| Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Gepotidacin | Therapeutic Success | 69 | Participants | |
| Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Therapeutic Success | 17 | Participants | |
| Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Gepotidacin | Therapeutic Failure | 14 | Participants | |
| Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Therapeutic Failure | 8 | Participants | |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Gepotidacin | Clinical Resolution | 71 | Participants | |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Clinical Resolution | 19 | Participants | |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Gepotidacin | Clinical Improvement | 5 | Participants | |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Clinical Improvement | 4 | Participants |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gepotidacin | 286 | |
| Overall Study | STARTED | Nitrofurantoin | 94 | |
| Overall Study | ITT Population | Gepotidacin | 281 | |
| Overall Study | ITT Population | Nitrofurantoin | 93 | |
| Overall Study | Microbiological ITT (Micro-ITT) | Gepotidacin | 88 | |
| Overall Study | Microbiological ITT (Micro-ITT) | Nitrofurantoin | 29 | |
| Overall Study | Micro-ITT NTF-S | Gepotidacin | 83 | |
| Overall Study | Micro-ITT NTF-S | Nitrofurantoin | 25 | |
| Overall Study | Micro-ITT MDR | Gepotidacin | 18 | |
| Overall Study | Micro-ITT MDR | Nitrofurantoin | 3 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events10
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 | 167 | 281 | 175 |
| other | Diarrhoea | Gastrointestinal disorders | Nitrofurantoin | 7 | 93 | 9 |
| other | Nausea | Gastrointestinal disorders | Gepotidacin | 35 | 281 | 35 |
| other | Nausea | Gastrointestinal disorders | Nitrofurantoin | 2 | 93 | 2 |
| serious | Diarrhoea | Gastrointestinal disorders | Gepotidacin | 1 | 281 | 1 |
| serious | Diarrhoea | Gastrointestinal disorders | Nitrofurantoin | 0 | 93 | 0 |
| serious | Vomiting | Gastrointestinal disorders | Gepotidacin | 1 | 281 | 1 |
| serious | Vomiting | Gastrointestinal disorders | Nitrofurantoin | 0 | 93 | 0 |
| serious | Clostridium difficile infection | Infections and infestations | Gepotidacin | 1 | 281 | 1 |
| serious | Clostridium difficile infection | Infections and infestations | Nitrofurantoin | 0 | 93 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gepotidacin | 0 | 281 |
| Total, all-cause mortality | Nitrofurantoin | 0 | 93 |
| Total, other adverse events | Gepotidacin | 174 | 281 |
| Total, other adverse events | Nitrofurantoin | 8 | 93 |
| Total, serious adverse events | Gepotidacin | 2 | 281 |
| Total, serious adverse events | Nitrofurantoin | 0 | 93 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gepotidacin vs Nitrofurantoin: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Gepotidacin vs Nitrofurantoin: deaths from any cause | Trial comparisons |
| Gepotidacin vs Nitrofurantoin: 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/NCT05630833
GET https://conductscience.org/api/trials/v1/NCT05630833/registered?page=2