Clinical Trials Directory

Trials / Completed

CompletedNCT00938002

Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients

Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).

Status
Completed
Phase
Study type
Observational
Enrollment
37 (actual)
Sponsor
Denver Health and Hospital Authority · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Critically ill patients on a breathing machine are at risk of developing a type of pneumonia called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The study also plans to test the accuracy and speed of a new technology, using multiplexed automated digital microscopy, to identify the germs causing the VAP.

Detailed description

Ventilator-associated pneumonia (VAP) is a common, life-threatening hospital-acquired infectious complication of prolonged mechanical ventilation (MV). Despite aggressive efforts to prevent VAP, rates remain high because clinical diagnosis is imprecise and microbiological diagnosis is frequently delayed. Diagnosis of VAP depends on clinical signs as well as microbiologic evidence from Bronchioalveolar Lavage (BAL) cultures. Ordinarily, these cultures are only ordered after the patient presents with clinical signs and symptoms of VAP, which can significantly delay diagnosis and effective therapy. This research proposes to implement additional surveillance BAL cultures in order to reduce the time to diagnosis of VAP in mechanically ventilated critically ill adults. To further reduce the time to diagnosis of VAP, this research aims to test part of the BAL cultures using a novel flowcell/surface-capture device that allows direct from specimen visualization of bacteria using multiplexed automated digital microscopy (BACcel™) for rapid bacterial identification and antibiotic resistance testing. Additionally, molecular assays of the BAL sample will characterize lower respiratory tract antimicrobial peptide host-innate immune molecule and local anti-oxidant defenses in mechanically ventilated adults at risk for VAP.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTAcceler8 Pheno

Timeline

Start date
2009-07-01
Primary completion
2019-09-19
Completion
2019-09-19
First posted
2009-07-13
Last updated
2019-12-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00938002. Inclusion in this directory is not an endorsement.