Health Trials

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 groups

Locations

5
Helsingborg hospital Helsingborg Sweden
Kristianstad hospital Kristianstad Sweden
Skåne University Hospital, Lund Lund Sweden
Skåne University Hospital, Malmö Malmö Sweden

Sponsors and collaborators

Lund University

Lead sponsor

Source ClinicalTrials.gov