Conditions: Wound Infection Abscess Systemic Inflammation Cellulitis
Keywords: ABSSSI Skin Infection Abscess
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 968
Healthy volunteers: no

Brief 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.

Detailed description:
This was 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 ABSSSI suspected or proven to be caused by gram-positive pathogens. Approximately 960 participants were to be randomized at 100 centers globally.

In addition, this study characterized the pharmacokinetics (PK) and PK/pharmacodynamics (PD) properties of a single 1200-mg IV dose of oritavancin and evaluated 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 3: Placebo
Intervention descriptions: intervention 1: Oritavancin was administered as a single IV dose. intervention 2: Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days. intervention 3: Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo).

Protocol document: