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Pivmecillinam vs Nitrofurantoin for UTI

MB
Overseen ByMatthew Bardin, PharmD, BCPS
Age: < 18
Sex: Female
Trial Phase: Phase 2
Sponsor: Alembic Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for girls ages 12 to under 18 who have an uncomplicated urinary tract infection (UTI). Participants should be generally healthy aside from the UTI and not have complicated or chronic kidney problems.

Inclusion Criteria

Written informed consent from parent(s) or legally acceptable representative(s), and informed assent from participant before initiation of any trial-related procedures
Urine specimen positive for nitrite, pyuria, or presence of 3 plus (+)/large leukocyte esterase confirmed by leukocyte esterase via urine dipstick or urinalysis, or > 10 WBCs per microliter from unspun urine or > 5 WBCs per high power field from centrifuged specimen
I have at least two new urinary symptoms like pain, urgency, or frequency in the last 4 days.
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Exclusion Criteria

I have a history of porphyria.
I have taken antibiotics by mouth or injection in the past 7 days.
Pregnancy or lactation or considering becoming pregnant
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What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two antibiotics, pivmecillinam (Pivya) and nitrofurantoin, to see which works better and is safer for treating UTIs in adolescent girls. Patients are randomly assigned to one of the two treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PivyaExperimental Treatment1 Intervention
Group II: NitrofurantoinActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alembic Therapeutics

Lead Sponsor

FOTREA CRO

Collaborator

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