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

Last updated on November 8, 2019

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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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Descriptive Information
Brief Title  ICMJE Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official Title  ICMJE Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
Brief SummaryTo determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin/Soft Tissue Infections
  • Methicillin Resistant Staphylococcus Aureus (MRSA)
Intervention  ICMJE
  • Drug: linezolid
  • Drug: vancomycin
Study Arms  ICMJE Not Provided
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2008)
1077
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion DateJuly 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Chile,   Colombia,   Italy,   Malaysia,   Mexico,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   United Kingdom,   United States,   Venezuela
Removed Location CountriesGermany,   Ireland
 
Administrative Information
NCT Number  ICMJE NCT00087490
Other Study ID Numbers  ICMJE A5951002
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 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 the study website. Please see the references below:

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