Conditions: Skin Infections, Bacterial
Keywords: methicillin-resistant Staphylococcus aureus linezolid repeat dose GSK1322322
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

Detailed description:
This is a phase IIa, multicenter, randomized, parallel group, double-blind, double dummy study to assess the safety, tolerability, and efficacy of GSK1322322 when given as 1500mg twice daily over a 10-day period versus linezolid (600mg twice daily for 10 days) in adults with suspected Gram positive Acute Bacterial Skin and Skin Structure Infection who are not currently receiving antibacterial therapy. Subjects will be randomized (2:1) to GSK1322322 or linezolid. This study consists of a screening visit, a 10-day treatment period, and follow-up evaluations 7 and 28 days following the last dose.

Arms:
arm 1: GSK1322322 1500mg and Placebo Linezolid given twice a day (BID) for 10 days arm 2: Linezolid 600mg and placebo GSK1322322 given BID for 10 days

Interventions: intervention 1: GSK1322322 intervention 2: Linezolid intervention 3: GSK1322322 placebo intervention 4: Linezolid placebo
Intervention descriptions: intervention 1: GSK1322322 1500mg BID intervention 2: Linezolid 600mg intervention 3: Placebo intervention 4: placebo

Protocol document: