A Study to Investigate Pivmecillinam Versus Nitrofurantoin in Female Adolescents 12 to Less Than 18 Years of Age With Uncomplicated Urinary Tract Infection

Conditions

• Uncomplicated Urinary Tract Infections

Eligibility Criteria

Sex

FEMALE

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Pivya (Pivmecillinam 185 mg) — DRUG
  Pivmecillinam 185 mg TID for 5 days, taken orally with or without food
• Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) — DRUG
  100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food

Study Details

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

Key Dates

First listed

Oct 13, 2026

Start date

Oct 24, 2026

Status verified

Oct 2026

Primary completion

Oct 30, 2027

Completion

Feb 28, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pivya
  185 mg (pivmecillinam HCl 200 mg, henceforth referred to as pivmecillinam 185 mg) TID for 5 days, taken orally with or without food
• Active Comparator: Nitrofurantoin
  100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events [ Time Frame: From enrollment to the end of treatment at 5 days ]

Central Contacts

• Matthew Bardin, PharmD, BCPS
  (908) 569-7456
  [email protected]

Locations (1)

Find similar trials in Dearborn Heights, MI