Trial Outcomes & Findings for 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 NCT06597344)
NCT ID: NCT06597344
Last Updated: 2026-02-11
Results Overview
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.
COMPLETED
PHASE3
97 participants
At 24 hours (h) (±4 h)
2026-02-11
Participant Flow
Participant milestones
| Measure |
Gepotidacin
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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|---|---|
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Overall Study
STARTED
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97
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Overall Study
COMPLETED
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96
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Gepotidacin
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Gepotidacin
n=97 Participants
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Age, Continuous
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45.7 YEARS
STANDARD_DEVIATION 16.39 • n=41 Participants
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Sex: Female, Male
Female
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97 Participants
n=41 Participants
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Sex: Female, Male
Male
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0 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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55 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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42 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Race/Ethnicity, Customized
White
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69 Participants
n=41 Participants
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Race/Ethnicity, Customized
Black or African American
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20 Participants
n=41 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=41 Participants
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Race/Ethnicity, Customized
American Indian or Alaska Native
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1 Participants
n=41 Participants
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Race/Ethnicity, Customized
Multiple
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1 Participants
n=41 Participants
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Race/Ethnicity, Customized
Not Reported
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2 Participants
n=41 Participants
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Race/Ethnicity, Customized
Unknown
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2 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: At 24 hours (h) (±4 h)Population: 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)
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.
Outcome measures
| Measure |
Gepotidacin
n=90 Participants
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours)
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54.4 Percentage of participants
Interval 43.6 to 65.0
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SECONDARY outcome
Timeframe: At 48 hours (h) (±4 h), 72 hours (±4 h), 96 hours (±4 h)Population: 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.
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.
Outcome measures
| Measure |
Gepotidacin
n=90 Participants
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Percentage of Participants Achieving Clinical Symptom Improvement
48 hours (±4 h)
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79.8 Percentage of participants
Interval 69.9 to 87.6
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Percentage of Participants Achieving Clinical Symptom Improvement
72 hours (±4 h)
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90.0 Percentage of participants
Interval 81.9 to 95.3
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Percentage of Participants Achieving Clinical Symptom Improvement
96 hours (±4 h)
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86.5 Percentage of participants
Interval 77.6 to 92.8
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SECONDARY outcome
Timeframe: At 24 hours (±4 h), 48 hours (±4 h), 72 hours (±4 h), 96 hours (±4 h)Population: 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.
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.
Outcome measures
| Measure |
Gepotidacin
n=90 Participants
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Percentage of Participants Achieving Clinical Symptom Resolution
24 hours (±4 h)
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3.3 Percentage of participants
Interval 0.7 to 9.4
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Percentage of Participants Achieving Clinical Symptom Resolution
48 hours (±4 h)
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12.4 Percentage of participants
Interval 6.3 to 21.0
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Percentage of Participants Achieving Clinical Symptom Resolution
72 hours (±4 h)
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32.2 Percentage of participants
Interval 22.8 to 42.9
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Percentage of Participants Achieving Clinical Symptom Resolution
96 hours (±4 h)
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53.9 Percentage of participants
Interval 43.0 to 64.6
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SECONDARY outcome
Timeframe: Up to 159 daysPopulation: Safety population included all enrolled participants who received at least 1 dose of study intervention.
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%.
Outcome measures
| Measure |
Gepotidacin
n=97 Participants
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)
TEAEs
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27 Participants
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Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)
SAEs
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0 Participants
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Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)
AESIs
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23 Participants
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Adverse Events
Gepotidacin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gepotidacin
n=97 participants at risk
Participants with uncomplicated urinary tract infections received 1500 milligram (mg) (2 × 750 mg tablets) Gepotidacin orally as twice daily for 5 days totaling a daily dose of 3000 mg. Each dose was taken after food consumption and with water.
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Gastrointestinal disorders
Diarrhoea
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16.5%
16/97 • Number of events 16 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Gastrointestinal disorders
Flatulence
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6.2%
6/97 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Gastrointestinal disorders
Abdominal pain
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4.1%
4/97 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Gastrointestinal disorders
Abdominal discomfort
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2.1%
2/97 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Gastrointestinal disorders
Nausea
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2.1%
2/97 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Nervous system disorders
Dizziness
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5.2%
5/97 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Nervous system disorders
Headache
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3.1%
3/97 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 159 days.
Safety population included all enrolled participants who received at least 1 dose of study intervention.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER