CompletedPhase 3

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

United States410 participantsStarted 2009-04

Plain-language 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.

Who can participate

Age range2 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * his…

What they're measuring

Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen

Timeframe: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid

Trial details

NCT IDNCT00852540

SponsorStiefel, a GSK Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07

Results submitted2011-07-28