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Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) | Clinical Trials | Clareo Health

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Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)

NCT04187144•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

Eligibility

Age

12 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•The participant is \>=12 years of age at the time of signing the informed consent/assent and has a body weight \>=40 kilogram (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 (greater than \[\>\]15 white blood cell \[WBC\]/high-power field \[HPF\]) or the presence of 3 plus (+)/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
•The participant is female.
•The participant is capable of giving signed informed consent/assent.

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 defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
•The participant has any of the following:
•1. Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain,; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; Or
•2. Known acute porphyria.
•3. Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention .
•The participant has a known glucose-6 phosphate dehydrogenase deficiency.
•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.
+21 more criteria

Locations (113)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Homewood, Alabama, United States

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Gilbert, Arizona, United States

GSK Investigational Site

Peoria, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

La Mesa, California, United States

GSK Investigational Site

Modesto, California, United States

GSK Investigational Site

Northridge, California, United States

GSK Investigational Site

Sacramento, California, United States

Key Dates

Start Date

April 23, 2020

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2022

Last Updated

July 18, 2023

Enrollment

1,606

ACTUAL participants

Conditions

Urinary Tract Infections

Interventions

Gepotidacin

DRUG

Placebo matching nitrofurantoin

DRUG

Nitrofurantoin

DRUG

Placebo matching gepotidacin

DRUG

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

NCT05488340

Urinary Tract Infections

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RECRUITINGNA

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

NCT07233473

Urinary Tract Infections (UTIs)

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RECRUITING

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Inclusion Criteria

Exclusion Criteria

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Ureteral Stent Exchange Abstention in Urinary Tract Infections

Vaginal Ecosystem and Network in the United States Study

PRObiotics for KIdney Transplantation