NCT01209078

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

A Randomized, Double Blind, Double Dummy Multicenter Phase IIa Study to Assess Safety, Tolerability and Efficacy of GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Infections, Bacterial

Interventions

Type	Name	Description
DRUG	GSK1322322	GSK1322322 1500mg BID
DRUG	Linezolid	Linezolid 600mg
DRUG	GSK1322322 placebo	Placebo
DRUG	Linezolid placebo	placebo

Timeline

• Start date: 2010-08-17
• Primary completion: 2011-01-18
• Completion: 2011-01-18
• First posted: 2010-09-24
• Last updated: 2017-12-04
• Results posted: 2017-12-04

Locations

7 sites across 1 country: United States