At a glance
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A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
In Brief
A Phase 3 clinical trial evaluating Single-Dose IV Oritavancin Diphosphate, IV Vancomycin, and 1 other intervention for Wound Infection and 3 related conditions. Completed, enrolled 968 participants across 1 site.
Detailed Summary
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.
Study Details
Timeline
Interventions
Oritavancin was administered as a single IV dose.
Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days.
Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo).