drugset
drugset / Trial / NCT05599295

Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections

NCT05599295 ↗

Phase 2 Completed 118 enrolled Melinta Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs). This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both). The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.

Timeline

Start
2023-06-15
Primary completion
2025-11-20
Completion
2025-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Oritavancin Other / unclassified 15 mg/kg Intravenous

Indications

No indication recorded.