Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter 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
1 other identifier
interventional
410
1 country
53
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2009
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
February 27, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
August 26, 2011
CompletedMarch 27, 2017
February 1, 2017
1.2 years
February 26, 2009
July 28, 2011
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Secondary Outcomes (10)
Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants With Clinical Response at Follow-up
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen
2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen
2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
- +5 more secondary outcomes
Study Arms (2)
Retapamulin
EXPERIMENTALLinezolid
ACTIVE COMPARATORInterventions
Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days.
Adult and adolescent (=\>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects \<5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (53)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Bentonville, Arkansas, 72172, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Paragould, Arkansas, 72450, United States
GSK Investigational Site
Bakerfield, California, 93301, United States
GSK Investigational Site
Bell Gardens, California, 90201, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
Sacramento, California, 92585, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Atlantis, Florida, 33462, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33306, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Miami, Florida, 33144, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Vero Beach, Florida, 32960, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Macon, Georgia, 31217, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Overland Park, Kansas, 66215, United States
GSK Investigational Site
Louisville, Kentucky, 40217, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
Grand Blanc, Michigan, 48439, United States
GSK Investigational Site
Jackson, Mississippi, 39216-4505, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Brooklyn, New York, 11203, United States
GSK Investigational Site
Carlisle, Ohio, 45005, United States
GSK Investigational Site
Tulsa, Oklahoma, 74127, United States
GSK Investigational Site
Corvallis, Oregon, 97330, United States
GSK Investigational Site
Gresham, Oregon, 97030, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Hazleton, Pennsylvania, 18201, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Austin, Texas, 78734, United States
GSK Investigational Site
Dallas, Texas, 75204, United States
GSK Investigational Site
Dallas, Texas, 75390-9113, United States
GSK Investigational Site
Duncanville, Texas, 75116, United States
GSK Investigational Site
Fort Worth, Texas, 76107, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Charlottesville, Virginia, 22902, United States
GSK Investigational Site
Seattle, Washington, 98101, United States
Related Publications (1)
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.
PMID: 25396674DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
February 27, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2010
Study Completion
September 1, 2010
Last Updated
March 27, 2017
Results First Posted
August 26, 2011
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.