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

NCT00588588 | Withdrawn Phase 3

• 1 other identifier: 06-002660
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Ventilator associated pneumonia; Intensive Care; Antibiotics; Mortality; Length of stay

Outcome Measures

Primary Outcomes (1)

• 14-day antibiotic free days

  Day 14 of enrolment

Secondary Outcomes (3)

• Mortality

  28 days

• Daily organ failure score

  14 days

• Length of hospital stay

  Hospital stay

Study Arms (2)

1

ACTIVE COMPARATOR

Bronchoscopy

Procedure: Bronchoscopy

2

ACTIVE COMPARATOR

CPIS

Procedure: Clinical pulmonary infection score (CPIS)

Interventions

Bronchoscopy PROCEDURE

Bronchoscopy procedure

1

Clinical pulmonary infection score (CPIS) PROCEDURE

Calculate CPIS

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Related Publications (1)

• 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.

  PMID: 16528014 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Bekele Afessa, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 8, 2008
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 26, 2023

Record last verified: 2023-09