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

PHASE3CompletedINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

September 30, 2010

Conditions
Skin Infections, Bacterial
Interventions
DRUG

Retpamulin Ointment, 1%

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.

DRUG

Linezolid

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.

Trial Locations (53)

11203

GSK Investigational Site, Brooklyn

15212

GSK Investigational Site, Pittsburgh

18201

GSK Investigational Site, Hazleton

20037

GSK Investigational Site, Washington D.C.

22902

GSK Investigational Site, Charlottesville

31217

GSK Investigational Site, Macon

31406

GSK Investigational Site, Savannah

31904

GSK Investigational Site, Columbus

32504

GSK Investigational Site, Pensacola

32960

GSK Investigational Site, Vero Beach

33144

GSK Investigational Site, Miami

33306

GSK Investigational Site, Fort Lauderdale

33308

GSK Investigational Site, Fort Lauderdale

33401

GSK Investigational Site, West Palm Beach

33462

GSK Investigational Site, Atlantis

33710

GSK Investigational Site, St. Petersburg

33744

GSK Investigational Site, Bay Pines

35235

GSK Investigational Site, Birmingham

36207

GSK Investigational Site, Anniston

40217

GSK Investigational Site, Louisville

45005

GSK Investigational Site, Carlisle

46601

GSK Investigational Site, South Bend

48439

GSK Investigational Site, Grand Blanc

59701

GSK Investigational Site, Butte

66215

GSK Investigational Site, Overland Park

68114

GSK Investigational Site, Omaha

68131

GSK Investigational Site, Omaha

70112

GSK Investigational Site, New Orleans

72172

GSK Investigational Site, Bentonville

72401

GSK Investigational Site, Jonesboro

72450

GSK Investigational Site, Paragould

74127

GSK Investigational Site, Tulsa

75116

GSK Investigational Site, Duncanville

75204

GSK Investigational Site, Dallas

76107

GSK Investigational Site, Fort Worth

77030

GSK Investigational Site, Houston

78734

GSK Investigational Site, Austin

80909

GSK Investigational Site, Colorado Springs

84041

GSK Investigational Site, Layton

90201

GSK Investigational Site, Bell Gardens

90813

GSK Investigational Site, Long Beach

92585

GSK Investigational Site, Sacramento

92647

GSK Investigational Site, Huntington Beach

93301

GSK Investigational Site, Bakerfield

95661

GSK Investigational Site, Roseville

96813

GSK Investigational Site, Honolulu

96814

GSK Investigational Site, Honolulu

97030

GSK Investigational Site, Gresham

97210

GSK Investigational Site, Portland

97330

GSK Investigational Site, Corvallis

98101

GSK Investigational Site, Seattle

39216-4505

GSK Investigational Site, Jackson

75390-9113

GSK Investigational Site, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Stiefel, a GSK Company

INDUSTRY