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

Acute Bacterial Skin and Skin Structure Infection Clinical Trial

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 Skin and Skin Structure Infections

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infection
• Infections
• Skin Diseases, Bacterial

• NCT number: NCT05599295
• Study type: Interventional
• Source: Melinta Therapeutics, Inc.
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2023
• Completion date: January 15, 2026