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A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00484588
First Posted: June 11, 2007
Last Update Posted: June 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.

Condition Phase
Ventilator Associated Pneumonia Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: A Multi-Center Observational Surveillance of VAP Causing Bacteria Study

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 500
Study Start Date: May 2005
Estimated Study Completion Date: December 2006
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484588


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00484588     History of Changes
Other Study ID Numbers: 0918X-101828
First Submitted: June 8, 2007
First Posted: June 11, 2007
Last Update Posted: June 11, 2007
Last Verified: June 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
VAP

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury