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

Recruiting Phase 3 Interventional Study
Urinary Tract Infections Bacteremia Antibiotic Resistant Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 130
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
Lund University · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital 3. Clinical suspicion of UTI including at least one of the following symptoms: 1. Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic ha…
Contacts

Oskar Ljungquist, M.D, PhD

+46424063182

oskar.ljungquist@med.lu.se

CONTACT

Jonas Tverring, M.D, PhD

+46424062673

jonas.tverring@med.lu.se

CONTACT