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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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00588588
Enrollment
0
Registered
2008-01-08
Start date
2007-01-31
Completion date
2009-05-31
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

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

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.

Interventions

PROCEDUREBronchoscopy

Bronchoscopy procedure

PROCEDUREClinical pulmonary infection score (CPIS)

Calculate CPIS

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
14-day antibiotic free daysDay 14 of enrolment

Secondary

MeasureTime frame
Mortality28 days
Daily organ failure score14 days
Length of hospital stayHospital stay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026