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 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 219575
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 22

Brief Summary

The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

Conditions

Urinary Tract Infections

Keywords

Gepotidacin; Uncomplicated Urinary Tract Infection; Acute Cystitis; Symptom Improvement Study (SIS)

Outcome Measures

Primary Outcomes (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.

  At 24 hours (h) (±4 h)

Secondary Outcomes (3)

• Percentage of Participants Achieving Clinical Symptom Improvement

  At 48 hours (h) (±4 h), 72 hours (±4 h), 96 hours (±4 h)

• Percentage of Participants Achieving Clinical Symptom Resolution

  At 24 hours (±4 h), 48 hours (±4 h), 72 hours (±4 h), 96 hours (±4 h)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)

  Up to 159 days

Study Arms (1)

Gepotidacin

EXPERIMENTAL

Single Arm

Drug: Gepotidacin

Interventions

Gepotidacin DRUG

Gepotidacin will be administered.

Gepotidacin

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Modesto, California, 95350-5365, United States

Location

GSK Investigational Site

Pasadena, California, 91101-2453, United States

Location

GSK Investigational Site

San Diego, California, 92120-5259, United States

Location

GSK Investigational Site

Valencia, California, 91355, United States

Location

GSK Investigational Site

Miami, Florida, 33135, United States

Location

GSK Investigational Site

Ormond Beach, Florida, 32174-6302, United States

Location

GSK Investigational Site

Palm Springs, Florida, 33406-7671, United States

Location

GSK Investigational Site

Palm Springs, Florida, 33461, United States

Location

GSK Investigational Site

Plant City, Florida, 33563-4202, United States

Location

GSK Investigational Site

Sweetwater, Florida, 33172-2741, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409-3401, United States

Location

GSK Investigational Site

West New York, New Jersey, 07093-2622, United States

Location

GSK Investigational Site

New York, New York, 10016-7313, United States

Location

GSK Investigational Site

Dayton, Ohio, 45424, United States

Location

GSK Investigational Site

Forney, Texas, 75126-4174, United States

Location

GSK Investigational Site

Houston, Texas, 77036, United States

Location

GSK Investigational Site

Houston, Texas, 77087, United States

Location

GSK Investigational Site

Kingwood, Texas, 26537, United States

Location

GSK Investigational Site

Mesquite, Texas, 75149, United States

Location

GSK Investigational Site

Missouri City, Texas, 77459-4756, United States

Location

GSK Investigational Site

Bountiful, Utah, 84010-4943, United States

Location

GSK Investigational Site

Morgantown, West Virginia, 26501, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

gepotidacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 2, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (22)