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Bronchoscopy vs. Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP)

NCT00588588 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-26

No results posted yet for this study

Summary

The reported incidence of ventilator associated pneumonia (VAP) is 10 to 15 per 1,000 ventilator days. VAP leads to an excess cost exceeding $40,000 per patient and is associated with a crude mortality rate as high as 76%. The clinical criteria for the diagnosis of VAP have low specificity and may lead to unnecessary antibiotic use. The Clinical Pulmonary Infection Score (CPIS) and bronchoscopic approaches lower unnecessary antimicrobial use, antimicrobial resistance, and superinfection compared to the traditional clinical criteria.

Based on the available evidence and local microbiology data, we have developed a VAP management protocol guided by CPIS or bronchoalveolar lavage (BAL) in adults with suspected VAP. These two approaches have not been compared against each other. Although the diagnostic studies in the CPIS guided approach are inexpensive and easily available, BAL has the potential to minimize the unnecessary use of antibiotics and reduce the development of drug resistant pathogens.

In this study, we propose to test the hypothesis that BAL leads to a reduction in antibiotic use compared to CPIS in patients with suspected VAP. The study design will be a randomized, clinical trial comparing CPIS versus BAL. The primary outcome measure will be antibiotic utilization. The secondary outcome measures will be mortality, morbidity, development of resistant pathogens and superinfection and infection related financial burden.

Completion of this trial will help us identify the best approach to avoid unnecessary antibiotic utilization and minimize the development of resistant pathogens (with their associated morbidity and mortality) in critically ill patients.

Conditions

  • Ventilator Associated Pneumonia

Interventions

PROCEDURE

Bronchoscopy

Bronchoscopy procedure

PROCEDURE

Clinical pulmonary infection score (CPIS)

Calculate CPIS

Sponsors & Collaborators

Principal Investigators

  • Bekele Afessa, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00588588 on ClinicalTrials.gov