drugset / Trial / NCT05224401
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
RandomizedParallel-groupSingle-blindTreatment
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).
Timeline
- Start
- 2023-05-29
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
Publications
- Background Saad S, Mina N, Lee C, Afra K. Oral beta-lactam step down in bacteremic E. coli urinary tract infections. BMC Infect Dis. 2020 Oct 21;20(1):785. doi: 10.1186/s12879-020-05498-2.
- Tverring J, Mansson E, Andrews V, Ljungquist O. Pivmecillinam with Amoxicillin/Clavulanic acid as step down oral therapy in febrile Urinary Tract Infections caused by ESBL-producing Enterobacterales (PACUTI). Trials. 2023 Sep 2;24(1):568. doi: 10.1186/s13063-023-07542-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 500 mg | Oral |
| Subject | Amoxicillin | Other / unclassified | 875 mg | Oral |
| Comparator | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Comparator | Ertapenem | Small molecule | 1 g | Intravenous |
| Subject | Pivmecillinam | Small molecule | 400 mg | Oral |
| Comparator | Sulfamethoxazole | Small molecule | 160 mg | Oral |
| Comparator | Trimethoprim | Small molecule | 800 mg | Oral |
| Subject | clavulanic acid | Small molecule | 125 mg | Oral |