Multicenter, Randomized, Open-label, Active-controlled Study With a Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride Versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, With Uncomplicated Urinary Tract Infections
Alembic Therapeutics
Summary
Multicenter, Randomized, Open-label, Active-controlled Study with Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, with Uncomplicated Urinary Tract Infections
Description
This is a Phase 2 multicenter, randomized, open-label, active-controlled trial with a blinded assessor of pivmecillinam versus nitrofurantoin in female pediatric participants 12 years to less than 18 years of age with uUTI. Approximately 100 female pediatric participants will be randomized 2:1 to pivmecillinam or nitrofurantoin. Randomized participants will take pivmecillinam (185 mg, three times daily \[TID\] orally) or nitrofurantoin (100 mg, twice daily \[BID\] orally) for 5 days. The screening visit can occur up to 24 hours prior to the first dose of trial drug. Therefore, the screening…
Eligibility
- Age range
- 12–17 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Female adolescents 12 years to less than 18 years of age at the time of consent and a body weight ≥ 40 kg (≥ 88 lbs). 2. Written informed consent from parent(s) or legally acceptable representative(s), and informed assent from participant (according to the local regulations) before initiation of any trial-related procedures. 3. Able to supply a urine specimen from clean-catch midstream urine sample. 4. Have 2 or more of the following clinical signs and symptoms of acute cystitis with onset ≤ 96 hours prior to trial entry: dysuria, urinary frequency, urinary urgency, or…
Interventions
- DrugPivya (Pivmecillinam 185 mg)
Pivmecillinam 185 mg TID for 5 days, taken orally with or without food
- DrugNitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)
100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food
Location
- Alembic Clinical Trial SiteDearborn Heights, Michigan