Bronchoscopy vs. Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP)
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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.
Condition | Intervention | Phase |
---|---|---|
Ventilator Associated Pneumonia |
Procedure: Bronchoscopy Procedure: Clinical pulmonary infection score (CPIS) |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Bronchoscopy Versus Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP): Randomized Clinical Trial |
- 14-day antibiotic free days [ Time Frame: Day 14 of enrolment ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Daily organ failure score [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Length of hospital stay [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]
Enrollment: | 0 |
Study Start Date: | January 2007 |
Study Completion Date: | May 2009 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
Bronchoscopy
|
Procedure: Bronchoscopy
Bronchoscopy procedure
|
Active Comparator: 2
CPIS
|
Procedure: Clinical pulmonary infection score (CPIS)
Calculate CPIS
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >= 18 years
- Endotracheal intubation
- Suspected VAP with:
- New or progressive pulmonary infiltrates plus two of the following (In patients with pre-existing ALI or ARDS, physicians' suspicion of VAP with two of the listed criteria will be used.): Temperature > 38 C or < 36 C, WBC > 12,000/mL or < 4,000/mL, purulent endotracheal secretions.
- Patient or legally authorized representative is able to sign Informed Consent
Exclusion Criteria:
- Prison inmates
- Immunocompromised patients
- Participation in another trial conflicting with the design of the current trial
- Previous history of VAP during the same hospitalization
- Previous participation in the current study
- Concomitant non-pulmonary infection diagnosed within 3 days preceding the suspected VAP
- Patient's primary care provider does not want subject to be enrolled in the study
- Contraindications for bronchoscopy
Additional Information:
Publications:
Responsible Party: | Bekele Afessa, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588588 History of Changes |
Other Study ID Numbers: | 06-002660 |
Study First Received: | December 22, 2007 |
Last Updated: | January 24, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
Ventilator associated pneumonia Intensive Care Antibiotics Mortality Length of stay |
Additional relevant MeSH terms:
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
ClinicalTrials.gov processed this record on October 17, 2012