Trial · NCT06597344
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
NCT06597344, Phase 3, Completed, GlaxoSmithKline; results first posted 2026-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis). Trials, record NCT06597344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06597344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
- NCT number
- NCT06597344
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 97 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Urinary Tract Infections
- Interventions
- Gepotidacin
- First posted
- 2024-09-19
- Last updated
- 2026-02-11
- Results first posted
- 2026-02-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours) | At 24 hours (h) (±4 h) | Clinical Symptom improvement is defined as a decrease from Baseline in CSS (Clinical Symptom Score) total score of at least 1 point at 24 hours (±4 hours), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms. |
| Secondary | Percentage of Participants Achieving Clinical Symptom Improvement | At 48 hours (h) (±4 h), 72 hours (±4 h), 96 hours (±4 h) | Clinical Symptom improvement is defined as a decrease from Baseline in CSS total score of at least 1 point at each timepoint(i.e.,48 hours (±4 hours), 72 hours (±4 hours), and 96 hours (±4 hours)), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms. |
| Secondary | Percentage of Participants Achieving Clinical Symptom Resolution | At 24 hours (±4 h), 48 hours (±4 h), 72 hours (±4 h), 96 hours (±4 h) | Clinical Symptom resolution is defined as a decrease from Baseline to a CSS total score of 0 at each timepoint(i.e., 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), and 96 hours (±4 hours)) without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs) | Up to 159 days | Adverse Event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death,is life-threatening,required hospitalization or prolongation of existing hospitalization,resulted in disability/incapacity,is congenital anomaly/birth defect, other situations which involved medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs displayed are TEAEs defined as any AE with an onset date/time on or after treatment start date/time. AESIs include cardiovascular(CV) AEs, gastrointestinal(GI) AEs, clostridioides difficile-associated diarrhea (C. difficile AEs), Acetylcholinesterase Inhibition(AchE-I). AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). The AE data presented below is of frequency threshold-0%. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours) | At 24 hours (h) (±4 h) | Clinically Evaluable (CE) at 24 hours (+4 h) population included all participants in the Intent-to-treat (ITT) population (all participants who enrolled in the study) who adhered to the 2 doses of treatment as prescribed before the 24 hours (±4 hours) CSS assessment (if available), or, before 24 hours (+4 hours) from first dose (if CSS assessment is missing) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Symptom Improvement | At 48 hours (h) (±4 h), 72 hours (±4 h), 96 hours (±4 h) | CE 48/ 72/ 96 population included all participants in the ITT population who were able to adhere to at least 80% of planned doses of gepotidacin as prescribed before the 48 h (±4 h)/72 h (±4 h)/96 h (+4 h) CSS assessment (if available), or, before 48 h (±4 h)/ 72 h(+4 h)/ 96 h (+4 h) from first dose (if CSS assessment is missing). Only those participants with data available at specified time points have been analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Symptom Resolution | At 24 hours (±4 h), 48 hours (±4 h), 72 hours (±4 h), 96 hours (±4 h) | CE 48/ 72/ 96 population included all participants in the ITT population who were able to adhere to at least 80% of planned doses of gepotidacin as prescribed before the 48 h (±4 h)/72 h (±4 h)/96 h (+4 h) CSS assessment (if available), or, before 48 h (±4 h)/ 72 h(+4 h)/ 96 h (+4 h) from first dose (if CSS assessment is missing). Only those participants with data available at specified time points have been analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs) | Up to 159 days | Safety population included all enrolled participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours) | Gepotidacin | 54.4 | 95% Confidence Interval 43.6 to 65.0 | Percentage of participants | |
| Percentage of Participants Achieving Clinical Symptom Improvement | Gepotidacin | 48 hours (±4 h) | 79.8 | 95% Confidence Interval 69.9 to 87.6 | Percentage of participants |
| Percentage of Participants Achieving Clinical Symptom Improvement | Gepotidacin | 72 hours (±4 h) | 90.0 | 95% Confidence Interval 81.9 to 95.3 | Percentage of participants |
| Percentage of Participants Achieving Clinical Symptom Improvement | Gepotidacin | 96 hours (±4 h) | 86.5 | 95% Confidence Interval 77.6 to 92.8 | Percentage of participants |
| Percentage of Participants Achieving Clinical Symptom Resolution | Gepotidacin | 24 hours (±4 h) | 3.3 | 95% Confidence Interval 0.7 to 9.4 | Percentage of participants |
| Percentage of Participants Achieving Clinical Symptom Resolution | Gepotidacin | 48 hours (±4 h) | 12.4 | 95% Confidence Interval 6.3 to 21.0 | Percentage of participants |
| Percentage of Participants Achieving Clinical Symptom Resolution | Gepotidacin | 72 hours (±4 h) | 32.2 | 95% Confidence Interval 22.8 to 42.9 | Percentage of participants |
| Percentage of Participants Achieving Clinical Symptom Resolution | Gepotidacin | 96 hours (±4 h) | 53.9 | 95% Confidence Interval 43.0 to 64.6 | Percentage of participants |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs) | Gepotidacin | TEAEs | 27 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs) | Gepotidacin | SAEs | 0 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gepotidacin | 97 | |
| Overall Study | COMPLETED | Gepotidacin | 96 | |
| Overall Study | NOT COMPLETED | Gepotidacin | 1 |
Source ClinicalTrials.gov
Adverse events7
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 | 16 | 97 | 16 |
| other | Flatulence | Gastrointestinal disorders | Gepotidacin | 6 | 97 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Gepotidacin | 4 | 97 | 4 |
| other | Abdominal discomfort | Gastrointestinal disorders | Gepotidacin | 2 | 97 | 2 |
| other | Nausea | Gastrointestinal disorders | Gepotidacin | 2 | 97 | 2 |
| other | Dizziness | Nervous system disorders | Gepotidacin | 5 | 97 | 6 |
| other | Headache | Nervous system disorders | Gepotidacin | 3 | 97 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gepotidacin | 0 | 97 |
| Total, other adverse events | Gepotidacin | 23 | 97 |
| Total, serious adverse events | Gepotidacin | 0 | 97 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42809288 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT06597344
GET https://conductscience.org/api/trials/v1/NCT06597344/registered