Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin
Status:
Not yet recruiting
Trial end date:
2025-12-15
Target enrollment:
Participant gender:
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 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 (i.e., applies to both).
The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome
assessments. The study was designed to capture adequate data while minimizing the impact to
subjects and their caregivers.