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First received: October 20, 2022

Clinical Trial: Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Study Status: Completed

Recruit Status: RECRUITING

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 IV Oritavancin vs SoC for the Treatment of Pediatric Subjects With Acute Bacterial

Brief Summary: This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs).This study involves two oritavancin products, ORBACTIV® and KIMYRSATM.Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA.This study protocol distinguishes the differences between ORBACTIV…

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