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RECRUITING
NCT05224401
PHASE3

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

Sponsor: Lund University

View on ClinicalTrials.gov

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

DRUG

Pivmecillinam and amoxicillin/clavulanic acid

1 tablet pivmecillinam 400 mg and 1 tablet Amoxicillin/clavulanic acid 875/125 mg, three times daily.

DRUG

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