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

Phase 3

Withdrawn

• Conditions: Ventilator Associated Pneumonia
• Interventions: Procedure: Clinical pulmonary infection score (CPIS); Procedure: Bronchoscopy

• Registration Number: NCT00588588
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2008-01-08
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Clinical pulmonary infection score (CPIS)	CPIS
1	Bronchoscopy	Bronchoscopy

Primary Outcome Measures

Name	Time	Method
14-day antibiotic free days	Day 14 of enrolment

Secondary Outcome Measures

Name	Time	Method
Daily organ failure score	14 days
Length of hospital stay	Hospital stay
Mortality	28 days