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

Last updated: February 23, 2017
Sponsor: Stiefel, a GSK Company
Overall Status: Completed

Phase

3

Condition

Bacterial Infections

Soft Tissue Infections

Staphylococcal Infections

Treatment

N/A

Clinical Study ID

NCT00852540
110978
  • Ages > 2
  • All Genders

Study 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.

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

Total Participants: 410
Study Start date:
April 01, 2009
Estimated Completion Date:
September 30, 2010

Study 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 wounds and abrasions) or impetigo (bullous and non-bullous) due to MRSA. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects <18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion. Subjects with impetigo can have up to 10 lesions and the infected lesion(s) must not be more than 100 cm2 in area (or up to a maximum of 2% total body surface area for subjects <18 years of age), must not require surgical intervention and must be able to be appropriately treated with a topical antibiotic.

There are five study visits occurring over a 17-19 day period. At the baseline visit (Visit 1, day 1), subjects will be randomized to receive retapamulin (plus oral placebo) or linezolid (plus placebo ointment) in a 2:1 ratio. Retapamulin is applied twice daily for 5 days, and linezolid is dosed, depending on subject age, either twice or three times daily for 10 days. The on-therapy, end of therapy and follow-up visits are staggered due to the difference in duration of the treatment regimens. Subjects will be monitored and clinically evaluated at all postbaseline visits.

Randomization will be center-based and stratified by age (<5 years, ≥5 to <12 years, ≥12 years), performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential. Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.

Connect with a study center

  • GSK Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • GSK Investigational Site

    Bentonville, Arkansas 72172
    United States

    Site Not Available

  • GSK Investigational Site

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • GSK Investigational Site

    Paragould, Arkansas 72450
    United States

    Site Not Available

  • GSK Investigational Site

    Bakerfield, California 93301
    United States

    Site Not Available

  • GSK Investigational Site

    Bell Gardens, California 90201
    United States

    Site Not Available

  • GSK Investigational Site

    Huntington Beach, California 92647
    United States

    Site Not Available

  • GSK Investigational Site

    Long Beach, California 90813
    United States

    Site Not Available

  • GSK Investigational Site

    Roseville, California 95661
    United States

    Site Not Available

  • GSK Investigational Site

    Sacramento, California 92585
    United States

    Site Not Available

  • GSK Investigational Site

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • GSK Investigational Site

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • GSK Investigational Site

    Atlantis, Florida 33462
    United States

    Site Not Available

  • GSK Investigational Site

    Bay Pines, Florida 33744
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • GSK Investigational Site

    Ft. Lauderdale, Florida 33306
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33144
    United States

    Site Not Available

  • GSK Investigational Site

    Pensacola, Florida 32504
    United States

    Site Not Available

  • GSK Investigational Site

    St. Petersburg, Florida 33710
    United States

    Site Not Available

  • GSK Investigational Site

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • GSK Investigational Site

    Macon, Georgia 31217
    United States

    Site Not Available

  • GSK Investigational Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • GSK Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • GSK Investigational Site

    South Bend, Indiana 46601
    United States

    Site Not Available

  • GSK Investigational Site

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • GSK Investigational Site

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • GSK Investigational Site

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • GSK Investigational Site

    Butte, Montana 59701
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • GSK Investigational Site

    Brooklyn, New York 11203
    United States

    Site Not Available

  • GSK Investigational Site

    Carlisle, Ohio 45005
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74127
    United States

    Site Not Available

  • GSK Investigational Site

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • GSK Investigational Site

    Gresham, Oregon 97030
    United States

    Site Not Available

  • GSK Investigational Site

    Portland, Oregon 97210
    United States

    Site Not Available

  • GSK Investigational Site

    Hazleton, Pennsylvania 18201
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78734
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75390-9113
    United States

    Site Not Available

  • GSK Investigational Site

    Duncanville, Texas 75116
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • GSK Investigational Site

    Layton, Utah 84041
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville, Virginia 22902
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98101
    United States

    Site Not Available

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