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Trial record 1 of 1 for:    NCT00572559
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Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

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ClinicalTrials.gov Identifier: NCT00572559
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : June 9, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 11, 2007
First Posted Date  ICMJE December 13, 2007
Last Update Posted Date June 9, 2010
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
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 Measures  ICMJE
 (submitted: December 11, 2007)
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.
Change History Complete list of historical versions of study NCT00572559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • 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 Measures  ICMJE
 (submitted: December 11, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
Official Title  ICMJE 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)
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia, Ventilator-Associated
Intervention  ICMJE
  • Drug: Vancomycin
    1 gram IV every 12 hours for 7 to 14 days
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Vancomycin
  • Experimental: 2
    Intervention: Drug: Linezolid
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2008)
149
Original Actual Enrollment  ICMJE
 (submitted: December 11, 2007)
146
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00572559
Other Study ID Numbers  ICMJE 766-INF-0026-126
A5951069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP