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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05599295 | Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections | PHASE2 | COMPLETED | 118 | — | — | Jun 15, 2023 | Nov 20, 2025 | Nov 25, 2025 | 23 | United States, Bulgaria +6 |
| Arm | Type | Description |
|---|---|---|
| Orbactiv | EXPERIMENTAL | Orbactiv will be infused at 15 milligrams/kilogram (mg/kg) over 3 hours for all participants and will not exceed a dose of 1200 mg. |
| Kimyrsa | EXPERIMENTAL | Kimyrsa will be infused at 15 mg/kg over 3 hours for all participants and will not exceed a dose of 1200 mg. |
| Name | Type | Description |
|---|---|---|
| Orbactiv | DRUG | Solution for IV infusion |
| Kimyrsa | DRUG | Solution for IV infusion |
Inclusion Criteria: 1. Male or female, 3 months to \<12 years of age at randomization 2. Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen): 1. Wound infection: that is either traumatic or surgical in origin, defined as an in...