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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Linezolid; Methicillin

Criteria

Inclusion Criteria:

• 2 months of age or older

• diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or non-bullous)

• negative urine pregnancy test (females of childbearing potential)

• total skin infection rating scale (SIRS) score of at least 8, which must include a pus/exudate score of at least 3

• subject or parent/legal guardian willing and able to comply with protocol

• written informed, dated consent, and written assent (if applicable)

Exclusion Criteria:

• previous hypersensitivity to pleuromutilins or oxazolidinones

• phenylketonuria or known hypersensitivity to aspartame

• secondarily-infected animal/human bite, or puncture wound

• abscess

• chronic ulcerative lesion

• underlying skin disease (eg, eczematous dermatitis) with secondary infection

• systemic signs and symptoms of infection

• skin infection not appropriate for treatment by a topical antibiotic (eg, extensive cellulitis, furunculosis)

• subject requires surgical intervention for infection prior to study or likely will during the study

• receipt of systemic antibacterial or steroid, or application of any topical therapeutic agent directly to wound within 24 hours of entry into the study

• subject currently receiving adrenergic agents

• subject currently receiving serotonergic agents

• history of pseudomembranous colitis

• known, pre-existing myelosuppression, history of myelosuppression with linezolid use, or receiving a medication that produces bone marrow suppression

• history of siezures

• history of severe renal failure and undergoing dialysis

• serious underlying disease that could be imminently life-threatening

• pregnant, breast feeding or planning a pregnancy, or not using accepted method of contraception (females of childbearing potential or <1 year post-menopausal)

• use of another investigational drug within 30 days prior to entry into this study

• previously enrolled in this study

• fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (for subjects <12 years of age receiving linezolid suspension)