Phase
Condition
Bacterial Infections
Soft Tissue Infections
Staphylococcal Infections
Treatment
N/AClinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
2 months of age or older
diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous ornon-bullous)
negative urine pregnancy test (females of childbearing potential)
total skin infection rating scale (SIRS) score of at least 8, which must include apus/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
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, extensivecellulitis, furunculosis)
subject requires surgical intervention for infection prior to study or likely willduring the study
receipt of systemic antibacterial or steroid, or application of any topicaltherapeutic 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 ofcontraception (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-isomaltaseinsufficiency (for subjects <12 years of age receiving linezolid suspension)
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Anniston, Alabama 36207
United StatesSite Not Available
GSK Investigational Site
Birmingham, Alabama 35235
United StatesSite Not Available
GSK Investigational Site
Bentonville, Arkansas 72172
United StatesSite Not Available
GSK Investigational Site
Jonesboro, Arkansas 72401
United StatesSite Not Available
GSK Investigational Site
Paragould, Arkansas 72450
United StatesSite Not Available
GSK Investigational Site
Bakerfield, California 93301
United StatesSite Not Available
GSK Investigational Site
Bell Gardens, California 90201
United StatesSite Not Available
GSK Investigational Site
Huntington Beach, California 92647
United StatesSite Not Available
GSK Investigational Site
Long Beach, California 90813
United StatesSite Not Available
GSK Investigational Site
Roseville, California 95661
United StatesSite Not Available
GSK Investigational Site
Sacramento, California 92585
United StatesSite Not Available
GSK Investigational Site
Colorado Springs, Colorado 80909
United StatesSite Not Available
GSK Investigational Site
Washington, District of Columbia 20037
United StatesSite Not Available
GSK Investigational Site
Atlantis, Florida 33462
United StatesSite Not Available
GSK Investigational Site
Bay Pines, Florida 33744
United StatesSite Not Available
GSK Investigational Site
Fort Lauderdale, Florida 33308
United StatesSite Not Available
GSK Investigational Site
Ft. Lauderdale, Florida 33306
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33144
United StatesSite Not Available
GSK Investigational Site
Pensacola, Florida 32504
United StatesSite Not Available
GSK Investigational Site
St. Petersburg, Florida 33710
United StatesSite Not Available
GSK Investigational Site
Vero Beach, Florida 32960
United StatesSite Not Available
GSK Investigational Site
West Palm Beach, Florida 33401
United StatesSite Not Available
GSK Investigational Site
Columbus, Georgia 31904
United StatesSite Not Available
GSK Investigational Site
Macon, Georgia 31217
United StatesSite Not Available
GSK Investigational Site
Savannah, Georgia 31406
United StatesSite Not Available
GSK Investigational Site
Honolulu, Hawaii 96814
United StatesSite Not Available
GSK Investigational Site
South Bend, Indiana 46601
United StatesSite Not Available
GSK Investigational Site
Overland Park, Kansas 66215
United StatesSite Not Available
GSK Investigational Site
Louisville, Kentucky 40217
United StatesSite Not Available
GSK Investigational Site
New Orleans, Louisiana 70112
United StatesSite Not Available
GSK Investigational Site
Grand Blanc, Michigan 48439
United StatesSite Not Available
GSK Investigational Site
Jackson, Mississippi 39216-4505
United StatesSite Not Available
GSK Investigational Site
Butte, Montana 59701
United StatesSite Not Available
GSK Investigational Site
Omaha, Nebraska 68131
United StatesSite Not Available
GSK Investigational Site
Brooklyn, New York 11203
United StatesSite Not Available
GSK Investigational Site
Carlisle, Ohio 45005
United StatesSite Not Available
GSK Investigational Site
Tulsa, Oklahoma 74127
United StatesSite Not Available
GSK Investigational Site
Corvallis, Oregon 97330
United StatesSite Not Available
GSK Investigational Site
Gresham, Oregon 97030
United StatesSite Not Available
GSK Investigational Site
Portland, Oregon 97210
United StatesSite Not Available
GSK Investigational Site
Hazleton, Pennsylvania 18201
United StatesSite Not Available
GSK Investigational Site
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
GSK Investigational Site
Austin, Texas 78734
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75390-9113
United StatesSite Not Available
GSK Investigational Site
Duncanville, Texas 75116
United StatesSite Not Available
GSK Investigational Site
Fort Worth, Texas 76107
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77030
United StatesSite Not Available
GSK Investigational Site
Layton, Utah 84041
United StatesSite Not Available
GSK Investigational Site
Charlottesville, Virginia 22902
United StatesSite Not Available
GSK Investigational Site
Seattle, Washington 98101
United StatesSite Not Available
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