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Antibiotic

Gepotidacin for Urinary Tract Infection

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16)

Awards & highlights

Study Summary

This trial will compare the effectiveness of two antibiotics for treating uncomplicated UTIs in women.

Eligible Conditions

Urinary Tract Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (on or before day 1), on-therapy (days 2 to 5), and test of cure (days 9 to 16) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)

Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population

Secondary outcome measures

Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit

Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit

Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit

+30 more

Side effects data

From 2022 Phase 3 trial • 1531 Patients • NCT04020341

14%

Diarrhoea

11%

Nausea

Abdominal pain upper

Flatulence

Faeces soft

Headache

Dizziness

Urinary tract infection

Vomiting

Aspartate aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

Gepotidacin

Nitrofurantoin

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GepotidacinExperimental Treatment2 Interventions

Participants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo twice daily (BID); approximately every 12 hours for 5 days

Group II: NitrofurantoinActive Control2 Interventions

Participants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo matching nitrofurantoin

2020

Completed Phase 3

~3140

Gepotidacin

2020

Completed Phase 3

~4020

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,749 Previous Clinical Trials

8,065,945 Total Patients Enrolled

1 Trials studying Urinary Tract Infection

2,648 Patients Enrolled for Urinary Tract Infection

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,142,447 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for people who want to participate in this research?

"Yes, this research is currently seeking volunteers. The trial was first advertised on October 17th, 2019 and the most recent update was September 19th, 2022."

Answered by AI

How many individuals are being given the opportunity to participate in this trial?

"That is correct. According to information available on clinicaltrials.gov, this trial began recruiting patients on October 17th, 2019 and is still ongoing. They are looking for a total of 2500 participants across 42 different recruitment sites."

Answered by AI

At how many different sites is this research project being conducted?

"To make it as convenient as possible for patients, this trial is being conducted in 42 locations, which can be found in Austin, Scottdale, Clarksville and other cities. You will be asked to choose the site that is closest to you when you enroll."

Answered by AI

When will Gepotidacin be available for general use?

"Gepotidacin has received a safety rating of 3. This is because it has progressed to Phase 3 clinical trials, so there is some efficacy data as well as multiple rounds of data supporting its safety."

Answered by AI

Are Gepotidacin's clinical trials unique in any way?

"Gepotidacin was initially trialled in 2013 at Pediatric Nephrology Dialysis and Transplant Unit IRCCS Ca'Granda. So far, there is a completed body of work consisting of 34 studies. There are presently 10 actively recruiting trials, with a significant number of these studies being conducted out of Austin, Pennsylvania."

Answered by AI