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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

  • Female, Age > 18 years (no upper age limit, they just need to be living independently)

  • 2 or more of the signs associated with acute cystitis < 72 hours prior to first visit

    • dysuria, frequency, urgency, or lower abdominal pain

 

Exclusion Criteria

  • The participant resides in a nursing home or dependent care type-facility.

  • Acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens

    • I.e. any bacteria other than E. Coli

  • Another disease of the urinary tract

  • Foreign material in urinary tract such as ureter stents

  • Vaginal discharge at Baseline (suspected STI)

  • Cardiac inclusions such as heart failure or family history

  • Taken antibiotics/antifungals 1 week prior to baseline

Patients will be reimbursed for travel and food for study visits.