drugset / Trial / NCT06672978
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Phase 2
Active not recruiting
66 enrolled
Melinta Therapeutics, Inc.
Biomedical Advanced Research and Development Authority · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
Timeline
- Start
- 2025-06-03
- Primary completion
- 2027-01
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meropenem-Vaborbactam | Unknown | — | Intravenous |