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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00572559

Purpose

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.

Condition	Intervention	Phase
Pneumonia, Ventilator-Associated	Drug: Vancomycin Drug: Linezolid	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

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

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 72-96 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare duration of mechanical ventilation [ Time Frame: 0000 ] [ Designated as safety issue: No ]
To compare post treatment tracheal colonization [ Time Frame: FU: 14 days after EOT +/- 2 days ] [ Designated as safety issue: No ]
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score) [ Time Frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days ] [ Designated as safety issue: No ]
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure [ Time Frame: 72-96 hours ] [ Designated as safety issue: No ]
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU [ Time Frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days ] [ Designated as safety issue: No ]

Enrollment:	149
Study Start Date:	November 2002
Study Completion Date:	January 2005

Arms	Assigned Interventions
Experimental: 1	Drug: Vancomycin 1 gram IV every 12 hours for 7 to 14 days
Experimental: 2	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

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572559

Show 37 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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):1200-7. Epub 2008 Aug 21.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00572559 History of Changes
Other Study ID Numbers:	766-INF-0026-126, A5951069
Study First Received:	December 11, 2007
Last Updated:	June 8, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Pneumonia
Staphylococcal Infections
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury

Lung Injury
Methicillin
Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012