Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

NCT ID: NCT00572559

Last Updated: 2010-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-01-31

Brief Summary

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Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.

Detailed Description

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Conditions

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Pneumonia, Ventilator-Associated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

1 gram IV every 12 hours for 7 to 14 days

2

Group Type EXPERIMENTAL

Linezolid

Intervention Type DRUG

600 mg every 12 hours (intravenously \[IV\] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days

Interventions

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Vancomycin

1 gram IV every 12 hours for 7 to 14 days

Intervention Type DRUG

Linezolid

600 mg every 12 hours (intravenously \[IV\] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
* Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
* Clinical picture compatible with pneumonia (acquired during ventilation)
* Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia

Exclusion Criteria

* Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
* Infections due to gram-positive organisms known to be resistant to either of the study drugs.
* Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
* Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
* Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

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Redlands, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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Norwalk, Connecticut, United States

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Waterbury, Connecticut, United States

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Waterbury, Connecticut, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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North East Atlanta, Georgia, United States

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North East Atlanta, Georgia, United States

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North East Atlanta, Georgia, United States

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‘Ewa Beach, Hawaii, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Peoria, Illinois, United States

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Peoria, Illinois, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Buffalo, New York, United States

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Cortland Manor, New York, United States

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Jamaica, New York, United States

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The Bronx, New York, United States

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Cincinnati, Ohio, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Pfizer Investigational Site

Spokane, Washington, United States

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Pfizer Investigational Site

Morgantown, West Virginia, United States

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Pfizer Investigational Site

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Wunderink RG, Mendelson MH, Somero MS, Fabian TC, May AK, Bhattacharyya H, Leeper KV Jr, Solomkin JS. Early microbiological response to linezolid vs vancomycin in ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus. Chest. 2008 Dec;134(6):1200-1207. doi: 10.1378/chest.08-0011. Epub 2008 Aug 21.

Reference Type DERIVED
PMID: 18719064 (View on PubMed)

Other Identifiers

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A5951069

Identifier Type: -

Identifier Source: secondary_id

766-INF-0026-126

Identifier Type: -

Identifier Source: org_study_id

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