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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02134301 | Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections | PHASE1 | COMPLETED | 41 | — | — | May 1, 2014 | Nov 4, 2025 | Dec 12, 2025 | 8 | United States |
PK parameters (AUC)
| Arm | Type | Description |
|---|---|---|
| Oritavancin | EXPERIMENTAL | Single-dose IV Oritavancin Diphosphate |
| Name | Type | Description |
|---|---|---|
| Oritavancin | DRUG | - |
Inclusion Criteria: * Males and females \<18 years of age. * Neonates must be at least 34 weeks post-conception age. * Parent or legal guardian has given informed consent, as appropriate; and pediatric participant has given verbal assent where appropriate. * Suspected or diagnosed Gram-positive bac...