A Multi-Center Observational Surveillance Study of VAP Causing Bacteria

A Multi-Center Observational Surveillance of VAP Causing Bacteria Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00484588

Enrollment

500

Registered

2007-06-11

Start date

2005-05-31

Completion date

2006-12-31

Last updated

2007-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

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 \> 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.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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.

Outcome results