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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00572559
First received: December 11, 2007
Last updated: June 8, 2010
Last verified: June 2010
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Ventilator-Associated
Pneumonia
Staphylococcal Infections
Bacterial Infections
Cross Infection
Gram-Positive Bacterial Infections
Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury
Linezolid
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014