Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients
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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). |
- 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) |
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 |
Critically ill ventilated patients
Inclusion Criteria:
- Written, informed consent (by surrogate if unconscious or if altered mental status)
- ≥ 18 years old
- Admission to a Medical Intensive care unit
- Orally/nasally intubated, evaluable within 72 h of initial intubation
- Expected to remain mechanically ventilated for at least 48 h after the first study procedure
Exclusion Criteria:
- Previously documented cystic fibrosis
- Diffuse bronchiectasis
- Severe or massive hemoptysis
- Presence of an advanced directive to withhold life-sustaining treatment
- Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition
- Participation in a clinical trial of any unlicensed drug or device within 30 days
- Pregnant or Nursing
Contacts and Locations| United States, Colorado | |
| Denver Health Medical Center | |
| Denver, Colorado, United States, 80204 | |
| 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: | September 27, 2012 |
| 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 May 19, 2013