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Study of Uncomplicated Urinary Tract Infection in Females - Phase 3
A study aimed at determining the effectiveness of Gepotidiacin (new potential antibiotic) vs Nitrofurantoin (Current standard of care) in the treatment of uncomplicated female UTIs. Gepotidacin: 1500 mg administered orally twice daily (BID) for 5 days (Note: Each dose should be taken after food consumption and with water to assist with tolerability.)
Patients’ time commitments: Total = ~ 4.5 hours distributed over 4 weeks
4 visits (Baseline, On Therapy, Test of Cure & Follow up)
Baseline (first study visit): Visit takes approximately 45 mins (clinical trial explanation, consent forms, physical examination, ECG, biological samples collection & administration of treatment).
On Therapy Visit: approximately 2 hours (physical examination, 1.5hr post-dose ECG, biological sample collection).
Test of Cure will take 25 minutes (AE monitoring, biological sample collection)
Follow-up Visit: approximately 30 minutes (biological sample collection & AE monitoring).
Inclusion Criteria
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Female, Age > 18 years (no upper age limit, they just need to be living independently)
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2 or more of the signs associated with acute cystitis < 72 hours prior to first visit
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dysuria, frequency, urgency, or lower abdominal pain
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Exclusion Criteria
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The participant resides in a nursing home or dependent care type-facility.
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Acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens
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I.e. any bacteria other than E. Coli
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Another disease of the urinary tract
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Foreign material in urinary tract such as ureter stents
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Vaginal discharge at Baseline (suspected STI)
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Cardiac inclusions such as heart failure or family history
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Taken antibiotics/antifungals 1 week prior to baseline
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