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

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36106 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Skin/Soft Tissue Infections, Methicillin Resistant Staphylococcus Aureus (MRSA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00087490
Pfizer
Completed
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

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Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Skin/Soft Tissue Infections
  • Methicillin Resistant Staphylococcus Aureus (MRSA)
  • Drug: linezolid
  • Drug: vancomycin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1077
July 2007
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Chile,   Colombia,   Italy,   Malaysia,   Mexico,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   United Kingdom,   United States,   Venezuela
Germany,   Ireland
 
NCT00087490
A5951002
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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