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A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

Last updated on November 15, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ventilator Associated Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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NCT00484588
Pfizer
Completed
A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

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Descriptive Information
Brief TitleA Multi-Center Observational Surveillance Study of VAP Causing Bacteria
Official TitleA Multi-Center Observational Surveillance of VAP Causing Bacteria Study
Brief SummaryDetect 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 TypeObservational
Study DesignObservational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionVentilator Associated Pneumonia
InterventionNot Provided
Study Groups/CohortsNot 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 StatusCompleted
Enrollment
 (submitted: June 8, 2007)
500
Original EnrollmentSame as current
Study Completion DateDecember 2006
Primary Completion DateNot 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00484588
Other Study ID Numbers0918X-101828
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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[email protected]

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