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

Bronchoscopy Versus Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP): Randomized Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Procedure: Bronchoscopy; Procedure: Clinical pulmonary infection score (CPIS)

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Bronchoscopy	Procedure: Bronchoscopy; Bronchoscopy procedure
Active Comparator: 2; CPIS	Procedure: Clinical pulmonary infection score (CPIS); Calculate CPIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
14-day antibiotic free days	Day 14 of enrolment

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days
Length of hospital stay	Hospital stay
Daily organ failure score	14 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bekele Afessa, MD, Mayo Clinic

Publications and helpful links

General Publications

• Afessa B, Hubmayr RD, Vetter EA, Keegan MT, Swanson KL, Baddour LM, Cockerill FR 3rd, Peters SG. Bronchoscopy in ventilator-associated pneumonia: agreement of calibrated loop and serial dilution. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1229-32. doi: 10.1164/rccm.200512-1899OC. Epub 2006 Mar 9.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 22, 2007
• First Submitted That Met QC Criteria: December 22, 2007
• First Posted (Estimated): January 8, 2008

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Antibiotics; Mortality; Intensive Care; Ventilator associated pneumonia; Length of stay
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 06-002660