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Antibacterial

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 adolescent and adult 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)

Absolute Mean Values of Urine Specific Gravity

Change From Baseline in Body Temperature

+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 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

Gepotidacin

2020

Completed Phase 3

~4020

Placebo matching nitrofurantoin

2020

Completed Phase 3

~3140

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,753 Previous Clinical Trials

8,067,852 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

6,142,324 Total Patients Enrolled

Frequently Asked Questions

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

What is known about Gepotidacin from past research?

"Gepotidacin was first researched in 2013 by the Pediatric Nephrology Dialysis and Transplant Unit IRCCS Ca'Granda. As of now, 34 trials have been completed while 10 are still ongoing. The majority of active clinical trials for this medication are based in Plant City, Florida."

Answered by AI