Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06672978 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis | PHASE2 | RECRUITING | 66 | — | — | Jun 3, 2025 | Jul 1, 2027 | Apr 30, 2026 | 26 | United States, Bulgaria +4 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Age 6 to < 12 years | EXPERIMENTAL | Participants will receive meropenem-vaborbactam via an IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3. |
| Cohort 2: Age 2 to < 6 years | EXPERIMENTAL | Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3. |
| Cohort 3: Age 3 months to < 2 years | EXPERIMENTAL | Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3. |
| Name | Type | Description |
|---|---|---|
| Meropenem-Vaborbactam | DRUG | Administered as specified in the treatment arm |
| Antibiotics | DRUG | Administered as prescribed by the study physician in accordance with local guidelines and regulations. |
Key Inclusion Criteria: * Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics. * Evidence of pyuria, confirmed by either of the following: * A urine specimen that is ...