A Multi-Center Observational Surveillance Study of VAP Causing Bacteria
|ClinicalTrials.gov Identifier: NCT00484588|
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
|Condition or disease||Phase|
|Ventilator Associated Pneumonia||Phase 4|
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:
- Fever > 38.3ºC or hypothermia < 36ºC;
- WBC count > 10,000/mm3 or < 5,000/mm3, and/or purulent endoctracheal aspirate;
- 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|
|Estimated Enrollment :||500 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||A Multi-Center Observational Surveillance of VAP Causing Bacteria Study|
|Study Start Date :||May 2005|
|Estimated Study Completion Date :||December 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484588
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|