Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antibiotics · 1 trial · 2 indications
| 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 ...