Trial · NCT04187144
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
NCT04187144, Phase 3, Completed, GlaxoSmithKline; results first posted 2023-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI). Trials, record NCT04187144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04187144
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
- NCT number
- NCT04187144
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,606 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Urinary Tract Infections
- Interventions
- Gepotidacin, Placebo matching nitrofurantoin, Nitrofurantoin, Placebo matching gepotidacin
- First posted
- 2019-12-05
- Last updated
- 2023-07-18
- Other registries' IDs
- eudract:2020-000553-27
- Results first posted
- 2023-07-18
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 Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | 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 Baseline \[BL\] 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 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. |
| Primary | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | 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 Baseline \[BL\] 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 | TOC visit (Days 9 to 16) | Clinical outcomes at TOC were 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 baseline (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 | 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 | TOC Visit (Days 9 to 16) | Participant-level MOs at TOC were 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 | 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)s 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) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to \<10\^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit \[or AB for uUTI on day of FU visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Secondary | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met). |
| Secondary | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure. |
| Secondary | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10\^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU. |
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 Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | TOC visit (Days 9 to 16) | Microbiological intent-to-treat susceptible to nitrofurantoin - (Micro-ITT NTF-S) (Interim Analysis \[IA\] Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | TOC visit (Days 9 to 16) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | 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 | 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 | 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 | TOC visit (Days 9 to 16) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Micro-ITT NTF-S population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group472
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 Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Gepotidacin | Therapeutic Success | 162 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Nitrofurantoin | Therapeutic Success | 115 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Gepotidacin | Therapeutic Failure | 115 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Nitrofurantoin | Therapeutic Failure | 149 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Gepotidacin | Therapeutic Success | 172 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Therapeutic Success | 121 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Gepotidacin | Therapeutic Failure | 120 | Participants | |
| Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Therapeutic Failure | 154 | Participants | |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Gepotidacin | Clinical Resolution | 199 | Participants | |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Nitrofurantoin | Clinical Resolution | 175 | Participants |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 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 | 805 | |
| Overall Study | STARTED | Nitrofurantoin | 800 | |
| Overall Study | Safety Population | Gepotidacin | 804 | |
| Overall Study | Safety Population | Nitrofurantoin | 798 | |
| Overall Study | Microbiological ITT (Micro ITT) Population | Gepotidacin | 331 | |
| Overall Study | Microbiological ITT (Micro ITT) Population | Nitrofurantoin | 324 | |
| Overall Study | Micro-ITT NTF-S Population | Gepotidacin | 292 | |
| Overall Study | Micro-ITT NTF-S Population | Nitrofurantoin | 275 | |
| Overall Study | Micro-ITT NTF-S (IA Set) Population | Gepotidacin | 277 | |
| Overall Study | Micro-ITT NTF-S (IA Set) Population | Nitrofurantoin | 264 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events42
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 | 147 | 804 | 166 |
| other | Diarrhoea | Gastrointestinal disorders | Nitrofurantoin | 24 | 798 | 25 |
| other | Nausea | Gastrointestinal disorders | Gepotidacin | 65 | 804 | 66 |
| other | Nausea | Gastrointestinal disorders | Nitrofurantoin | 35 | 798 | 36 |
| other | Flatulence | Gastrointestinal disorders | Gepotidacin | 28 | 804 | 29 |
| other | Flatulence | Gastrointestinal disorders | Nitrofurantoin | 4 | 798 | 4 |
| other | Faeces soft | Gastrointestinal disorders | Gepotidacin | 23 | 804 | 30 |
| other | Faeces soft | Gastrointestinal disorders | Nitrofurantoin | 4 | 798 | 4 |
| other | Vomiting | Gastrointestinal disorders | Gepotidacin | 18 | 804 | 18 |
| other | Vomiting | Gastrointestinal disorders | Nitrofurantoin | 7 | 798 | 7 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gepotidacin | 0 | 804 |
| Total, all-cause mortality | Nitrofurantoin | 0 | 798 |
| Total, other adverse events | Gepotidacin | 235 | 804 |
| Total, other adverse events | Nitrofurantoin | 119 | 798 |
| Total, serious adverse events | Gepotidacin | 5 | 804 |
| Total, serious adverse events | Nitrofurantoin | 5 | 798 |
Source ClinicalTrials.gov
Papers11
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 comparisons4
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: Number of Participants With Serious Adverse Events (SAEs) | 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.
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