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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Accerl8 Technology Corporation
Information provided by (Responsible Party):
Ivor Douglas, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00938002
First received: July 10, 2009
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
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 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA collected from whole blood


Estimated Enrollment: 75
Study Start Date: July 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically ill ventilated patients

Criteria

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 ClinicalTrials.gov identifier: NCT00938002

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Accerl8 Technology Corporation
Investigators
Principal Investigator: Ivor S Douglas, MD Denver Health and Hospital Authority
Principal Investigator: Connie S Price, MD Denver Health and Hospital Authority
  More Information

No publications provided

Responsible Party: Ivor Douglas, Chief, Pulmonary Sciences & Critical Care Medicine, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00938002     History of Changes
Other Study ID Numbers: 09-0321, UL1RR025780
Study First Received: July 10, 2009
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Pneumonia
Pneumonia, Ventilator-Associated
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 31, 2014