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Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Last updated on November 9, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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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- Hospitalized male and female subjects with clinically documented nosocomial pneumonia
proven to be due to methicillin-resistant staphylococcus aureus.

- Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the
diagnosis of pneumonia.

- Suitable sputum specimen defined as having less than 10 squamous epithelial cells and
greater or equal 25 leukocytes or have a culture taken by an invasive technique
within 24 hours of study entry.

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 with MRSA activity (other than
linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment
failure (72 hours of treatment and not responding).

- Subjects with severe neutropenia (

- Subjects with hypersensitivity to oxazolidinones or vancomycin.

NCT00084266
Pfizer
Completed
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

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Descriptive Information
Brief Title  ICMJE Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official Title  ICMJE Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
Brief SummaryTo determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Methicillin Resistant Staphylococcus Aureus (MRSA)
Intervention  ICMJE
  • Drug: linezolid (Zyvox)
    Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Other Name: Zyvox, linezolid
  • Drug: vancomycin
    Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Study Arms  ICMJE
  • Experimental: 1
    Subjects receiving linezolid for the treatment phase of the study
    Intervention: Drug: linezolid (Zyvox)
  • Active Comparator: 2
    Subjects receiving vancomycin for the treatment phase of the study
    Intervention: Drug: vancomycin
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: March 7, 2011)
1225
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion DateMarch 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
  • Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
  • Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Exclusion Criteria:

  • Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
  • Subjects with severe neutropenia (<500 cells/mm3)
  • Subjects with hypersensitivity to oxazolidinones or vancomycin.
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,   France,   Germany,   Greece,   Hong Kong,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location CountriesItaly,   Singapore,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00084266
Other Study ID Numbers  ICMJE A5951001
Has Data Monitoring CommitteeNo
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 DateJanuary 2012

ICMJE     Data element required by the

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

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