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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open Label, Multi-Center Clinical Trial, Comparing Microbiologic Response To Linezolid And Vancomycin In Ventilator-Associated Pneumonia (VAP) Due To Methici

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.

Detailed Summary:
Sponsor: Pfizer

Current 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. [ Time Frame: 72-96 hours ]

Original 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.

Current Secondary Outcome:

  • To compare duration of mechanical ventilation [ Time Frame: 0000 ]
  • To compare post treatment tracheal colonization [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 72-96 hours ]
  • 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 ]


Original Secondary Outcome:

  • 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
  • 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 duration of mechanical ventilation


Information By: Pfizer

Dates:
Date Received: December 11, 2007
Date Started: November 2002
Date Completion:
Last Updated: June 8, 2010
Last Verified: June 2010