Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients
Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).
2 other identifiers
observational
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedDecember 24, 2019
December 1, 2019
10.2 years
July 10, 2009
December 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in time to diagnosis and treatment of VAP in an at risk population
30 days
Interventions
Eligibility Criteria
Critically ill ventilated patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Denver Health and Hospital Authoritylead
- Accerl8 Technology Corporationcollaborator
- National Center for Research Resources (NCRR)collaborator
Study Sites (1)
Denver Health Medical Center
Denver, Colorado, 80204, United States
Biospecimen
DNA collected from whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivor S Douglas, MD
Denver Health and Hospital Authority
- PRINCIPAL INVESTIGATOR
Connie S Price, MD
Denver Health and Hospital Authority
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Pulmonary Sciences & Critical Care Medicine
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
July 1, 2009
Primary Completion
September 19, 2019
Study Completion
September 19, 2019
Last Updated
December 24, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share