Text Size

A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00484588
First received: June 8, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00484588     History of Changes
Other Study ID Numbers: 0918X-101828
Study First Received: June 8, 2007
Last Updated: June 8, 2007
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 16, 2013