Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
A Randomized, Open Label, Multi-Center Clinical Trial, Comparing Microbiologic Response To Linezolid And Vancomycin In Ventilator-Associated Pneumonia (VAP) Due To Methicillin Resistant Staphylococcus Aureus (MRSA)
2 other identifiers
interventional
149
2 countries
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2002
Typical duration for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedJune 9, 2010
June 1, 2010
December 11, 2007
June 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.
72-96 hours
Secondary Outcomes (5)
To compare duration of mechanical ventilation
0000
To compare post treatment tracheal colonization
FU: 14 days after EOT +/- 2 days
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)
EOT: Day 14; FU: 14 days after EOT +/- 2 days
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure
72-96 hours
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU
EOT: Day 14; FU: 14 days after EOT +/- 2 days
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (37)
Pfizer Investigational Site
Phoenix, Arizona, 85006, United States
Pfizer Investigational Site
Phoenix, Arizona, 85012, United States
Pfizer Investigational Site
Palm Springs, California, 92262, United States
Pfizer Investigational Site
Rancho Mirage, California, 92270, United States
Pfizer Investigational Site
Redlands, California, 92373, United States
Pfizer Investigational Site
Sacramento, California, 95819, United States
Pfizer Investigational Site
Sacramento, California, 95829, United States
Pfizer Investigational Site
Norwalk, Connecticut, 06850, United States
Pfizer Investigational Site
Waterbury, Connecticut, 06708, United States
Pfizer Investigational Site
Waterbury, Connecticut, 06721, United States
Pfizer Investigational Site
Augusta, Georgia, 30909, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
North East Atlanta, Georgia, 30308, United States
Pfizer Investigational Site
North East Atlanta, Georgia, 30322, United States
Pfizer Investigational Site
North East Atlanta, Georgia, 30329, United States
Pfizer Investigational Site
‘Ewa Beach, Hawaii, 96706, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
Peoria, Illinois, 61603, United States
Pfizer Investigational Site
Peoria, Illinois, 61636, United States
Pfizer Investigational Site
Peoria, Illinois, 61637, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536, United States
Pfizer Investigational Site
Louisville, Kentucky, 40206, United States
Pfizer Investigational Site
Buffalo, New York, 14215, United States
Pfizer Investigational Site
Cortland Manor, New York, 10567, United States
Pfizer Investigational Site
Jamaica, New York, 11418, United States
Pfizer Investigational Site
The Bronx, New York, 10467, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559, United States
Pfizer Investigational Site
Memphis, Tennessee, 38103, United States
Pfizer Investigational Site
Memphis, Tennessee, 38104, United States
Pfizer Investigational Site
Memphis, Tennessee, 38163, United States
Pfizer Investigational Site
Nashville, Tennessee, 37212-3375, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Spokane, Washington, 99204, United States
Pfizer Investigational Site
Spokane, Washington, 99216, United States
Pfizer Investigational Site
Spokane, Washington, 99220, United States
Pfizer Investigational Site
Morgantown, West Virginia, 26505, United States
Pfizer Investigational Site
San Juan, 00921-3201, Puerto Rico
Related Publications (1)
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.
PMID: 18719064DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
November 1, 2002
Study Completion
January 1, 2005
Last Updated
June 9, 2010
Record last verified: 2010-06