Clinical trial NCT00938002: Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients
Official title: Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Acquired Pneumonia
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Accerl8 Technology Corporation
name: National Center for Research Resources (NCRR)
First posted: 2009-07-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill ventilated patients

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.

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 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

Primary outcomes:
measure: Reduction in time to diagnosis and treatment of VAP in an at risk population
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Ivor S Douglas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health and Hospital Authority
name: Connie S Price, MD
role: PRINCIPAL_INVESTIGATOR
References: