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First received: October 20, 2022

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Acute Bacterial Skin and Skin Structure Infection

Study Type: INTERVENTIONAL


Official Title: A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous Oritavancin for the Treatment of Pediatric Subjects With Acute Bacteri

Brief 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…

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