NCT05599295

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

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 Bacterial Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Melinta Therapeutics, LLC · Industry
• Sex: All
• Age: 3 Months – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Bacterial Skin and Skin Structure Infection

Interventions

Type	Name	Description
DRUG	Orbactiv	Solution for IV infusion
DRUG	Kimyrsa	Solution for IV infusion

Timeline

• Start date: 2023-06-15
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2022-10-31
• Last updated: 2025-11-25

Locations

23 sites across 8 countries: United States, Bulgaria, Greece, Latvia, Lithuania, Portugal, Romania, Spain

Regulatory

• FDA-regulated drug study