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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

Pivotal Trial

Summary

This trial compares two pills, gepotidacin and nitrofurantoin, to see which is better for treating UTIs in adolescent and adult women. Both aim to kill the bacteria causing the infection but use different methods. Nitrofurantoin has been used for a long time for the treatment of urinary tract infections (UTIs).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 2023 Phase 3 trial • 628 Patients • NCT04010539

49%

Diarrhoea

24%

Nausea

Vomiting

Flatulence

Abdominal Pain

Faeces soft

Dizziness

Chlamydial infection

Headache

Fatigue

Abdominal distension

Abdominal pain upper

Urethritis chlamydial

Hyperhidrosis

Vision blurred

Abdominal discomfort

Proctitis chlamydial

100%

80%

60%

40%

20%

Study treatment Arm

Gepotidacin

Ceftriaxone Plus Azithromycin

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Gepotidacin

2020

Completed Phase 3

~4410

Placebo matching nitrofurantoin

2020