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Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Sponsor: Lund University
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).
Official title: Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
330
Start Date
2023-05-29
Completion Date
2027-09-01
Last Updated
2023-08-28
Healthy Volunteers
No
Interventions
Pivmecillinam and amoxicillin/clavulanic acid
1 tablet pivmecillinam 400 mg and 1 tablet Amoxicillin/clavulanic acid 875/125 mg, three times daily.
Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem depending on susceptibility
Ciprofloxacin 500 mg twice daily, trimethoprim/sulfamethoxazole 800 mg/160 mg twice daily or ertapenem 1 g once daily.
Locations (5)
Helsingborg hospital
Helsingborg, Sweden
Kristianstad hospital
Kristianstad, Sweden
Skåne University Hospital, Lund
Lund, Sweden
Skåne University Hospital, Malmö
Malmo, Sweden
Västmanland hospital Västerås
Västerås, Sweden