Nosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00084266

Purpose

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to 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.

Condition	Intervention	Phase
Pneumonia, Staphylococcal	Drug: linezolid Drug: vancomycin	Phase IV

MedlinePlus related topics: Pneumonia

Drug Information available for: Vancomycin Linezolid Vancomycin hydrochloride Methicillin Methicillin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Linezolid in the Treatment of Subjects With Nosocomial Pneumonia Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Further study details as provided by Pfizer:

Primary Outcome Measures:

To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults [ Time Frame: up to 30 d after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults [ Time Frame: up to 30 days after end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1200
Study Start Date:	October 2004
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Subjects receiving linezolid for the treatment phase of the study	Drug: linezolid Subjects to receive either linezolid 600 mg IV or PO q 12 h for 7-14d, except in the presence of bacteremia, when it can continue for up to 21d.
2: Active Comparator Subjects receiving vancomycin for the treatment phase of the study	Drug: vancomycin Subjects to receive vancomycin 15mg/kg IV q12h (adjusted for renal function) for 7-14d, except in the presence of bacteremia, when it can continue for up to 21 d.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084266

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 171 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5951001
Study First Received:	June 9, 2004
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00084266
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Staphylococcal pneumonia, Methicillin-resistant staphylococcal pneumonia, healthcare-associated pneumonia

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Methicillin
Respiratory Tract Infections
Respiratory Tract Diseases

Pneumonia, Bacterial
Lung Diseases
Vancomycin
Linezolid
Pneumonia
Pneumonia, Staphylococcal

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009