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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Ventilator-Associated

Intervention: Vancomycin (Drug); Linezolid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To compare duration of mechanical ventilation

To compare post treatment tracheal colonization

To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)

To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure

To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, San Juan 00921-3201, Puerto Rico

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, Bronx, New York 10467, 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, 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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2002
Last updated: June 8, 2010

Page last updated: August 23, 2015

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