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Trial record 1 of 1 for:    NCT00484588
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A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

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ClinicalTrials.gov Identifier: NCT00484588
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date June 8, 2007
First Posted Date June 11, 2007
Last Update Posted Date June 11, 2007
Study Start Date May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multi-Center Observational Surveillance Study of VAP Causing Bacteria
Official Title A Multi-Center Observational Surveillance of VAP Causing Bacteria Study
Brief Summary Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.
Detailed Description

Any patient admitted into the chosen ICU will be a potential patient for this study. One of the main purposes of this study is to discover the various types of bacteria that cause VAP, and their frequency of occurrence. In order to obtain accurate and applicable results, as many subjects should be tested as possible. Approximately 500 patients will be included in this study.

VAP is defined as any lower respiratory tract infection that developed after 2 day of MV.

The criteria for clinical suspicion of pneumonia are as follows:

Presence of a new or persistent lung opacity on chest radiographs, plus two of the following items:

  1. Fever > 38.3ºC or hypothermia < 36ºC;
  2. WBC count > 10,000/mm3 or < 5,000/mm3, and/or purulent endoctracheal aspirate;
  3. Purulent endotracheal aspirate.

Every patient suspected of having pneumonia will undergo fiberoptic bronchoscopy to obtain samples by means of a bronchoalveolar lavage (BAL). VAP will be diagnosed based on results of BAL where BAL cultures yielding > 104 cfu/ml.

Study Type Observational
Study Design Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Ventilator Associated Pneumonia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†8,¬†2007)
500
Original Enrollment Same as current
Study Completion Date December 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion:

  • Patients hospitalized and mechanically ventilated for more than 48 hours are eligible for the study.
  • Fever > 38.3ºC or hypothermia < 36ºC or WBC count > 10,000/mm3.
  • Presence of a new or persistent lung opacity on chest radiographs.
  • Willing to provide informed legal consent. If the patient is a minor or incapacitated, legal consent may be given by a legal guardian or representative.

Exclustion:

  • Patients whose antibiotic strategy had been changed during the 3 days preceding the diagnostic procedure will not be included.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00484588
Other Study ID Numbers 0918X-101828
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2007