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

This study is ongoing, but not recruiting participants.
Accerl8 Technology Corporation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ivor Douglas, Denver Health and Hospital Authority Identifier:
First received: July 10, 2009
Last updated: August 14, 2016
Last verified: August 2016
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.

Ventilator Acquired Pneumonia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).

Resource links provided by NLM:

Further study details as provided by Ivor Douglas, Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Reduction in time to diagnosis and treatment of VAP in an at risk population [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA
DNA collected from whole blood

Enrollment: 37
Study Start Date: July 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill ventilated patients

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
  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 identifier: NCT00938002

United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Accerl8 Technology Corporation
National Center for Research Resources (NCRR)
Principal Investigator: Ivor S Douglas, MD Denver Health and Hospital Authority
Principal Investigator: Connie S Price, MD Denver Health and Hospital Authority
  More Information

Responsible Party: Ivor Douglas, Chief, Pulmonary Sciences & Critical Care Medicine, Denver Health and Hospital Authority Identifier: NCT00938002     History of Changes
Other Study ID Numbers: 09-0321
UL1RR025780 ( US NIH Grant/Contract Award Number )
Study First Received: July 10, 2009
Last Updated: August 14, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Critical Illness
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury processed this record on June 23, 2017