drugset / Trial / NCT03543436
Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections
Phase 3
Completed
29 enrolled
Assistance Publique - Hôpitaux de Paris
Fondation Hôpital Saint-Joseph · collabFrench National Network of Clinical Research in Infectious Diseases (RENARCI) · collabURC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.
Timeline
- Start
- 2019-01-04
- Primary completion
- 2020-10-29
- Completion
- 2020-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | IMIPENEM ANHYDROUS | Small molecule | 1 g | Intravenous |
| Comparator | Meropenem | Small molecule | 1 g | Intravenous |
| Subject | Temocillin | Small molecule | 2 g | Intravenous |
| Subject | Temocillin | Small molecule | 6 g | Intravenous |