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

This study has been withdrawn prior to enrollment.
(Due to inability to get support for the study)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588588
First received: December 22, 2007
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 14-day antibiotic free days [ Time Frame: Day 14 of enrolment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588588

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

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 July 24, 2014