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
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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COMPLETED
PHASE4
149 participants
INTERVENTIONAL
2002-11-30
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Vancomycin
1 gram IV every 12 hours for 7 to 14 days
2
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
Interventions
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Vancomycin
1 gram IV every 12 hours for 7 to 14 days
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
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
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Palm Springs, California, United States
Pfizer Investigational Site
Rancho Mirage, California, United States
Pfizer Investigational Site
Redlands, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
Norwalk, Connecticut, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Augusta, Georgia, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
North East Atlanta, Georgia, United States
Pfizer Investigational Site
North East Atlanta, Georgia, United States
Pfizer Investigational Site
North East Atlanta, Georgia, United States
Pfizer Investigational Site
‘Ewa Beach, Hawaii, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
Cortland Manor, New York, United States
Pfizer Investigational Site
Jamaica, New York, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Morgantown, West Virginia, United States
Pfizer Investigational Site
San Juan, , Puerto Rico
Countries
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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.
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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