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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588588
Recruitment Status : Withdrawn (Due to inability to get support for the study)
First Posted : January 8, 2008
Last Update Posted : January 25, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Procedure: Bronchoscopy Procedure: Clinical pulmonary infection score (CPIS) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bronchoscopy Versus Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP): Randomized Clinical Trial
Study Start Date : January 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: 1
Procedure: Bronchoscopy
Bronchoscopy procedure

Active Comparator: 2
Procedure: Clinical pulmonary infection score (CPIS)
Calculate CPIS

Primary Outcome Measures :
  1. 14-day antibiotic free days [ Time Frame: Day 14 of enrolment ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
  2. Daily organ failure score [ Time Frame: 14 days ]
  3. Length of hospital stay [ Time Frame: Hospital stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588588

Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Bekele Afessa, MD Mayo Clinic

Additional Information:
Responsible Party: Bekele Afessa, MD, Mayo Clinic Identifier: NCT00588588     History of Changes
Other Study ID Numbers: 06-002660
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Mayo Clinic:
Ventilator associated pneumonia
Intensive Care
Length of stay

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury