← Back to Search

Antibiotic

Gepotidacin for Urinary Tract Infections (SIS Trial)

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
Participants must be female
Participants must have nitrite or pyuria on a urine dipstick test from a pre-treatment clean-catch midstream urine sample
Must not have
Participants with a body mass index >=40.0 kilogram per meter square (kg/m^2) or >=35.0 kg/m^2 and experiencing obesity-related health conditions
Immunocompromised participants or those with altered immune defenses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), 96 hours (±4 hours)
Awards & highlights

Summary

"This trial will test if taking oral gepotidacin can improve symptoms and be safe for treating uncomplicated urinary tract infections in teenage and adult women."

Who is the study for?
This trial is for adolescent and adult female participants who are experiencing symptoms of an uncomplicated urinary tract infection (acute cystitis). Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.
What is being tested?
The trial is testing the effectiveness and safety of a medication called Gepotidacin. This oral drug is being studied to see if it can improve symptoms in females with uncomplicated UTI.
What are the potential side effects?
While specific side effects of Gepotidacin are not listed here, common side effects from antibiotics used to treat UTIs may include nausea, diarrhea, headache, dizziness, or yeast infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am female.
Select...
My urine test showed signs of infection.
Select...
I am 12 years or older and weigh at least 40 kg.
Select...
I have had symptoms like pain when urinating, needing to urinate often, a strong need to urinate, or lower belly pain in the last 4 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My BMI is 35 or higher with health issues related to obesity, or it's 40 or higher.
Select...
My immune system is weak or compromised.
Select...
I do not have uncontrolled asthma, COPD, severe pain, active ulcers, Parkinson's, Myasthenia gravis, or seizures needing medication.
Select...
I have a complicated or severe urinary tract infection.
Select...
I have a bladder infection that could affect the study's results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), 96 hours (±4 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), 96 hours (±4 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants achieving clinical symptom improvement at 24 hours (±4 hours)
Secondary study objectives
Percentage of participants achieving clinical symptom improvement
Percentage of participants achieving clinical symptom resolution

Side effects data

From 2023 Phase 3 trial • 628 Patients • NCT04010539
49%
Diarrhoea
24%
Nausea
6%
Vomiting
6%
Flatulence
5%
Abdominal Pain
5%
Faeces soft
5%
Dizziness
4%
Chlamydial infection
3%
Headache
3%
Fatigue
2%
Abdominal distension
2%
Abdominal pain upper
2%
Urethritis chlamydial
2%
Hyperhidrosis
2%
Vision blurred
1%
Abdominal discomfort
1%
Proctitis chlamydial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gepotidacin
Ceftriaxone Plus Azithromycin

Trial Design

1Treatment groups
Experimental Treatment
Group I: GepotidacinExperimental Treatment1 Intervention
Single Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gepotidacin
2020
Completed Phase 3
~4410

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,794 Previous Clinical Trials
8,177,571 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
2,648 Patients Enrolled for Urinary Tract Infection
~60 spots leftby Mar 2025