drugset / Trial / NCT05826990
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
NaSingle-groupOpen-labelTreatment
Summary
This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.
Timeline
- Start
- 2023-09-11
- Primary completion
- 2025-09-30
- Completion
- 2026-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefepime | Small molecule | — | Intravenous |
| Subject | enmetazobactam | Small molecule | — | Intravenous |