Clinical Trial

Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs

Study acronym: PACUTI
Recruiting Phase 3
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Summary
To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-01-25; most recent amendment 2023-08-25.
Status change: Not Yet Recruiting → Recruiting 2023-08-25
Trial Details
NCT Number NCT05224401
Lead Sponsor Lund University
Conditions Urinary Tract Infections, Bacteremia, Antibiotic Resistant Infection
Enrollment 330 participants
Start Date 2023-05-29
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2023-08-28