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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This study has been withdrawn prior to enrollment.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

December 22, 2007
January 24, 2012
January 2007
May 2009   (final data collection date for primary outcome measure)
14-day antibiotic free days [ Time Frame: Day 14 of enrolment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588588 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventilator Associated Pneumonia
  • Procedure: Bronchoscopy
    Bronchoscopy procedure
  • Procedure: Clinical pulmonary infection score (CPIS)
    Calculate CPIS
  • Active Comparator: 1
    Bronchoscopy
    Intervention: Procedure: Bronchoscopy
  • Active Comparator: 2
    CPIS
    Intervention: Procedure: Clinical pulmonary infection score (CPIS)
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. Epub 2006 Mar 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00588588
06-002660
No
Bekele Afessa, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Bekele Afessa, MD Mayo Clinic
Mayo Clinic
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP