Gepotidacin for Urinary Tract Infections (SIS Trial)

Phase 3

Recruiting

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

No Placebo-Only Group

Pivotal Trial

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

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I am female.

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My urine test showed signs of infection.

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I am 12 years or older and weigh at least 40 kg.

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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:

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My BMI is 35 or higher with health issues related to obesity, or it's 40 or higher.

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My immune system is weak or compromised.

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I do not have uncontrolled asthma, COPD, severe pain, active ulcers, Parkinson's, Myasthenia gravis, or seizures needing medication.

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I have a complicated or severe urinary tract infection.

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I have a bladder infection that could affect the study's results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), 96 hours (±4 hours)

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.