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

Condition(s) targeted: Staphylococcal Skin Infections

Intervention: linezolid (Drug); vancomycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare the clinical efficacy of linezolid to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects at the End of Study (EOS) visit

Secondary outcome:

To compare the clinical efficacy, and safety and tolerability of linezolid to vancomycin in the treatment of cSSTI due to MRSA in adult subjects at the End of Treatment (EOT) visit.

To compare the bacteriological efficacy, and safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

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

Starting date: October 2004
Last updated: December 5, 2007