Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorLund University
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).
Eligibility criteria
Qualifiers
Age ≥ 18 years
Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital
Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic haematuria or increased urinary frequency
Low abdominal pain or flank pain with percussion or palpation tenderness over kidneys and/or bladder.
Disqualifiers
Known or suspected pregnancy.
Known or suspected life-threatening allergy towards beta-lactam antibiotics.
Clinical isolate of EPE is resistant to ciprofloxacin, TMX and ertapenem.
Severe renal insufficiency with estimated glomerular filtration rate (eGFR) <10mL/min or requiring any form of dialysis.
Trial design
Treatments tested in this trial
- Pivmecillinam and amoxicillin/clavulanic acid
- Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem depending on susceptibility
Treatment groups
330 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov