Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

NCT00087490 | Completed Phase 4 Results

• 1 other identifier: A5951002
• Study Type: interventional
• Target: 1,077
• Locations: 16 countries
• Sites: 126

Brief Summary

To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects

Conditions

Skin/Soft Tissue Infections; Methicillin Resistant Staphylococcus Aureus (MRSA)

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population

  Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.

  EOS (6 to 28 days after the last dose of study drug)

Secondary Outcomes (14)

• Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population

  EOT (within 72 hours of last dose of study drug)

• Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population

  EOS (6 to 28 days after the last dose of study drug)

• Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population

  EOT (within 72 hours of last dose of study drug)

• Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population

  EOS (6 to 28 days after the last dose of study drug)

• Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population

  EOT (within 72 hours of last dose of study drug)

Interventions

linezolid DRUG

vancomycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
• Signs and symptoms consistent with infection
• Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

You may not qualify if:

• Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
• Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
• Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (126)

Pfizer Investigational Site

Montgomery, Alabama, 36106, United States

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Tucson, Arizona, 85723, United States

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Los Angeles, California, 90033, United States

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Palm Springs, California, 92262, United States

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Rancho Mirage, California, 92270, United States

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San Pedro, California, 90732, United States

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Santa Fe Springs, California, 90670, United States

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Sylmar, California, 91342, United States

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Torrance, California, 90502, United States

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Torrance, California, 90503, United States

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Torrance, California, 90509, United States

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Denver, Colorado, 80205, United States

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Denver, Colorado, 80218, United States

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Hartford, Connecticut, 06102, United States

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Hartford, Connecticut, 06106, United States

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New Haven, Connecticut, 06510, United States

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New Haven, Connecticut, 06515, United States

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Atlantis, Florida, 33462, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33136, United States

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Pensacola, Florida, 32501-6390, United States

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Atlanta, Georgia, 30309, United States

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Augusta, Georgia, 30909, United States

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Blue Ridge, Georgia, 30513, United States

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Honolulu, Hawaii, 96813, United States

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Honolulu, Hawaii, 96817, United States

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Chicago, Illinois, 60637, United States

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Decatur, Illinois, 62526, United States

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Hines, Illinois, 60141, United States

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Maywood, Illinois, 60153, United States

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North Chicago, Illinois, 60064, United States

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Northlake, Illinois, 60164, United States

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Springfield, Illinois, 62701, United States

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Springfield, Illinois, 62702, United States

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Iowa City, Iowa, 52242, United States

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Louisville, Kentucky, 40202-1798, United States

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Louisville, Kentucky, 40217, United States

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Louisville, Kentucky, 40222, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21230, United States

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Baltimore, Maryland, 21237, United States

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Boston, Massachusetts, 02111, United States

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West Roxbury, Massachusetts, 02132, United States

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East Lansing, Michigan, 48824, United States

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Lansing, Michigan, 48912, United States

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Minneapolis, Minnesota, 55422-2998, United States

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Mpls, Minnesota, 55422, United States

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Saint Paul, Minnesota, 55101, United States

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Butte, Montana, 59701, United States

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Lincoln, Nebraska, 46851, United States

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Lincoln, Nebraska, 68510, United States

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Somers Point, New Jersey, 08244, United States

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Stony Brook, New York, 11794, United States

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Winston-Salem, North Carolina, 27103, United States

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Akron, Ohio, 44304, United States

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Akron, Ohio, 44309, United States

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Akron, Ohio, 44310, United States

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Columbus, Ohio, 43214, United States

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Columbus, Ohio, 43215, United States

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Toledo, Ohio, 43608, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19140, United States

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Philadelphia, Pennsylvania, 19141, United States

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West Reading, Pennsylvania, 19611, United States

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Ducktown, Tennessee, 37326, United States

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Jackson, Tennessee, 38301, United States

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Dallas, Texas, 75235, United States

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Dallas, Texas, 75390-9016, United States

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Dallas, Texas, 75390, United States

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Fort Worth, Texas, 76107, United States

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Forth Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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St. George, Utah, 84770, United States

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St. George, Utah, 84790, United States

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Tacoma, Washington, 98431, United States

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Buenos Aires, Buenos Aires, C1039AAO, Argentina

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Loma Hermosa, Buenos Aires, 1653, Argentina

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Buenos Aires, C1425DQK, Argentina

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Córdoba, 5000, Argentina

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Charleroi, 6000, Belgium

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Ghent, 9000, Belgium

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Montigny-le-Tilleul, 6110, Belgium

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São José do Rio Preto, São Paulo, 15090-000, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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Providencia, Santiago Metropolitan, Chile

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Santiago, Chile

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Floridablanca, Santander Department, Colombia

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Genova, 16132, Italy

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Napoli, 80131, Italy

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Roma, 00149, Italy

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Roma, 00168, Italy

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Udine, 33100, Italy

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Varese, 21100, Italy

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 50603, Malaysia

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Guadalajara, Jalisco, 44280, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Pragal, Almada, 2800-525, Portugal

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Amadora, 2720, Portugal

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Coimbra, 3090, Portugal

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Lisbon, 1449-005, Portugal

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Lisbon, Portugal

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Moscow, 119048, Russia

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Moscow, Russia

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Smolensk, Russia

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Singapore, Singapore, 529889, Singapore

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Kuilsriver, Western Province, 7580, South Africa

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Johannesburg, 2113, South Africa

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Parow, 7499, South Africa

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Pretoria, 0001, South Africa

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Pretoria, 0184, South Africa

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Córdoba, Cordoba, 14004, Spain

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Girona, Gerona, 17007, Spain

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Seville, Sevilla, 41013, Spain

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Winchester, Hampshire, SO22 5DG, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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Ciudad Bolívar, Bolívar, 8001, Venezuela

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Distrito Capital, Miranda, 1040, Venezuela

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Distrito Capital, Miranda, 1070, Venezuela

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Valencia, Valencia, 2002, Venezuela

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Maracaibo, Zulia, 4002, Venezuela

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Related Publications (2)

• Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.

  PMID: 24011955 DERIVED

• Itani KM, Biswas P, Reisman A, Bhattacharyya H, Baruch AM. Clinical efficacy of oral linezolid compared with intravenous vancomycin for the treatment of methicillin-resistant Staphylococcus aureus-complicated skin and soft tissue infections: a retrospective, propensity score-matched, case-control analysis. Clin Ther. 2012 Aug;34(8):1667-73.e1. doi: 10.1016/j.clinthera.2012.06.018. Epub 2012 Jul 6.

  PMID: 22770644 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Linezolid; Vancomycin

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Comparing duration of intravenous (IV) therapy for linezolid (LZD) and vancomycin (VAN) in study, participants in LZD group had option to switch to oral therapy while those in VAN group had to remain on IV therapy until completion of study treatment.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2004
• First Posted: July 13, 2004
• Study Start: October 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 8, 2012
• Results First Posted: August 8, 2012

Record last verified: 2012-06

Locations

BE (3); MY (2); ME (3); RU (3); CO (3); SG (1); US (76); ES (3); AR (4); CL (2); GB (3); BR (2); IT (6); VE (5); PT (5); ZA (5)