Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs (NCT05224401) | Clinical Trial Compass
RecruitingPhase 3
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Sweden330 participantsStarted 2023-05-29
Plain-language 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).
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital
✓. Clinical suspicion of UTI including at least one of the following symptoms:
✓. 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.
✓. Urine (≥ 103 CFU/mL) and/or blood culture positive for EPE\* with susceptibility to pivmecillinam†.
✓. In-patient who has received 1-5 days of EPE-active‡ intravenous antibiotics
✓. Discontinuing parenteral treatment and starting treatment with oral antibiotics is considered safe according to the treating physician.
Exclusion criteria
✕. 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.