Conditions: Wound Infection Abscess Systemic Inflammation Cellulitis
Keywords: ABSSSI Skin Infection Abscess
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1019
Healthy volunteers: no

Brief summary:
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a single 1200 mg IV dose.

Detailed description:
This is a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Approximately 960 patients will be randomized at 100 centers globally.

In addition, this study will characterize the PK and PK/PD properties of a single 1200 mg IV dose of oritavancin and evaluate the potential health economic benefits offered by this dosing strategy.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Single-Dose IV Oritavancin Diphosphate intervention 2: IV Vancomycin
Intervention descriptions: intervention 1: Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days. intervention 2: Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.

Protocol document: