Overview

This trial is active, not recruiting.

Condition ventilator acquired pneumonia
Sponsor Denver Health and Hospital Authority
Collaborator Accerl8 Technology Corporation
Start date July 2009
End date June 2017
Trial size 37 participants
Trial identifier NCT00938002, 09-0321, UL1RR025780

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Reduction in time to diagnosis and treatment of VAP in an at risk population
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Written, informed consent (by surrogate if unconscious or if altered mental status) 2. ≥ 18 years old 3. Admission to a Medical Intensive care unit 4. Orally/nasally intubated, evaluable within 72 h of initial intubation 5. Expected to remain mechanically ventilated for at least 48 h after the first study procedure Exclusion Criteria: 1. Previously documented cystic fibrosis 2. Diffuse bronchiectasis 3. Severe or massive hemoptysis 4. Presence of an advanced directive to withhold life-sustaining treatment 5. Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition 6. Participation in a clinical trial of any unlicensed drug or device within 30 days 7. Pregnant or Nursing

Additional Information

Official title Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).
Principal investigator Ivor S Douglas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Denver Health and Hospital Authority.