Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA

Summary

The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.

Timeline

Start

2009-04

Primary completion

2010-07

Completion

2010-09

Outcome

Missed primary endpoint

paper Clinical success rate at follow-up in the per-protocol MRSA population was significantly lower in the retapamulin versus the linezolid group. PMID 25396674 ↗

Publications

• Tanus T, Scangarella-Oman NE, Dalessandro M, Li G, Breton JJ, Tomayko JF. A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of secondarily infected traumatic lesions and impetigo due to methicillin-resistant Staphylococcus aureus. Adv Skin Wound Care. 2014 Dec;27(12):548-59. doi: 10.1097/01.ASW.0000456631.20389.ae.

Drugs

Indications