Trials / Recruiting
RecruitingNCT06672978
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) · Industry
- Sex
- All
- Age
- 3 Months – 11 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Meropenem-Vaborbactam | Administered as specified in the treatment arm |
| DRUG | Antibiotics | Administered as prescribed by the study physician in accordance with local guidelines and regulations. |
Timeline
- Start date
- 2025-06-03
- Primary completion
- 2027-01-01
- Completion
- 2027-07-01
- First posted
- 2024-11-04
- Last updated
- 2025-12-17
Locations
24 sites across 6 countries: United States, Bulgaria, Croatia, Georgia, Greece, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06672978. Inclusion in this directory is not an endorsement.