Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484588
Status:
COMPLETED
Last Update Posted:
2007-06-11
First Post:
2007-06-08
Brief Title:
A Multi-Center Observational Surveillance Study of VAP Causing Bacteria
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Multi-Center Observational Surveillance of VAP Causing Bacteria Study
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 383ºC or hypothermia 36ºC
2 WBC count 10000mm3 or 5000mm3 andor 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 cfuml
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 383ºC or hypothermia 36ºC
2 WBC count 10000mm3 or 5000mm3 andor 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 cfuml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None