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)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified December 2025 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT06597344
Other Study ID Numbers:
219575
First Submitted
September 2, 2024
First Posted
September 18, 2024
Results First Posted
December 11, 2025
Last Update Posted
February 10, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Urinary Tract Infections
Drug: Gepotidacin

Study Design

Study TypeInterventional
Actual Enrollment97 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3b, Open-label, Single-arm 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)
Study Start DateOctober 1, 2024
Actual Primary Completion DateMarch 9, 2025
Actual Study Completion DateMarch 9, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Gepotidacin
Single Arm
Drug: Gepotidacin
Gepotidacin will be administered.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours)
    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 Outcome Measures
  1. Percentage of Participants Achieving Clinical Symptom Improvement
    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.
  2. Percentage of Participants Achieving Clinical Symptom Resolution
    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.
  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)
    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%.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
Participants having \>=12 years of age at the time of signing the informed consent/assent and have a body weight \>=40 kilograms (kg).
The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset \<96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
The participant has nitrite or pyuria (presence of 3 plus (+)/large leukocyte esterase) on a urine dipstick test from a pre-treatment clean-catch midstream urine sample.
The participant is capable of giving signed informed consent/assent.
The participant is female.
Exclusion Criteria
The participant resides in a nursing home or dependent care type-facility.
The participant has a body mass index \>=40.0 kilogram per meter square (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes.
The participant has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation.
The participant is immunocompromised or has altered immune defences that may predispose the participant to a higher risk of treatment failure and/or complications.
The participant has any of the following:
Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain, Active peptic ulcer disease; Parkinson disease; Myasthenia gravis;
A history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures) Or
Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention.
The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
The participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period.
The participant has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than Escherichia coli) as the contributing pathogen.
The participant has symptoms known or suspected to be caused by another disease process, such as overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of uUTI symptoms.
The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (for example \[e.g.\], polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral reflux, detrusor insufficiency).
The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract.
The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset \>=96 hours before study entry, or a temperature \>=101.4 degree Fahrenheit (\>=38 Degrees Celsius \[°C\]), flank pain, chills, or any other manifestations suggestive of upper UTI.
The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<30 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator).
The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease).
The participant has congenital long QT syndrome or known prolongation of the QTc interval.
The participant has uncompensated heart failure.
The participant has severe left ventricular hypertrophy.
The participant has a family history of QT prolongation or sudden death.
The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsade de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-gp inhibitor
The participant has a mean triplicate QTc \>450 msec or a mean triplicate QTc \>480 msec for participants with bundle-branch block.
The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
The participant has a known ALT value \>2 times upper limit of normal (ULN).
The participant has a known bilirubin value \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]).
The participant has a current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C).
The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.
The participant plans to use any of the prohibited medications or nondrug therapies from the Baseline Visit through 7 days after the first dose of study intervention.
The participant has been previously enrolled in this study or has previously been treated with gepotidacin.
The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.

Contacts and Locations

Sponsors and CollaboratorsGlaxoSmithKline
Locations
GSK Investigational Site | Modesto California, United States, 95350-5365GSK Investigational Site | Pasadena California, United States, 91101-2453GSK Investigational Site | San Diego California, United States, 92120-5259GSK Investigational Site | Valencia California, United States, 91355GSK Investigational Site | Miami Florida, United States, 33135GSK Investigational Site | Ormond Beach Florida, United States, 32174-6302GSK Investigational Site | Palm Springs Florida, United States, 33406-7671GSK Investigational Site | Palm Springs Florida, United States, 33461GSK Investigational Site | Plant City Florida, United States, 33563-4202GSK Investigational Site | Sweetwater Florida, United States, 33172-2741GSK Investigational Site | West Palm Beach Florida, United States, 33409-3401GSK Investigational Site | West New York New Jersey, United States, 07093-2622GSK Investigational Site | New York New York, United States, 10016-7313GSK Investigational Site | Dayton Ohio, United States, 45424GSK Investigational Site | Forney Texas, United States, 75126-4174GSK Investigational Site | Houston Texas, United States, 77036GSK Investigational Site | Houston Texas, United States, 77087GSK Investigational Site | Kingwood Texas, United States, 26537GSK Investigational Site | Mesquite Texas, United States, 75149GSK Investigational Site | Missouri City Texas, United States, 77459-4756GSK Investigational Site | Bountiful Utah, United States, 84010-4943GSK Investigational Site | Morgantown West Virginia, United States, 26501
Study Documents (Full Text)
Documents provided by GlaxoSmithKline: Study Protocol  September 9, 2024Documents provided by GlaxoSmithKline: Statistical Analysis Plan  April 1, 2025