Status:
COMPLETED
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Skin Infections, Bacterial
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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 mon...
Detailed Description
This is a prospective, randomized, double-blind, double dummy, multicenter, comparative study in subjects 2 months of age and older with SITL (including secondarily-infected lacerations, sutured wound...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00852540
Start Date
April 1 2009
End Date
September 1 2010
Last Update
March 27 2017
Active Locations (53)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Birmingham, Alabama, United States, 35235
3
GSK Investigational Site
Bentonville, Arkansas, United States, 72172
4
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401