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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00938002
Recruitment Status : Active, not recruiting
First Posted : July 13, 2009
Last Update Posted : August 3, 2017
Accerl8 Technology Corporation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ivor Douglas, Denver Health and Hospital Authority

Brief 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.

Condition or disease
Ventilator Acquired Pneumonia

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.

Study Type : Observational
Actual Enrollment : 37 participants
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).
Study Start Date : July 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
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