Status:
ACTIVE_NOT_RECRUITING
Pneumonia Direct Pilot
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia, Bacterial
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Brief Summary
The Pneumonia Direct Pilot study is designed to assess whether combining molecular diagnostics for bacteria and AMR markers with host-response profiling improves agreement and predictive value for the...
Detailed Description
This is a prospective, observational, diagnostic, feasibility study to determine the accuracy of pathogen- and host-directed testing for the diagnosis of VAP. Newly intubated adult patients admitted t...
Eligibility Criteria
Inclusion
- Are ≥18 years old
- Are newly intubated for less than 48 hours and for reasons other than suspected bacterial pneumonia or suspected acute bacterial infection
- Are expected to require intubation for at least 48 hours, per the discretion of the treating clinician
- Are able to provide protocol-accepted consent (legally authorized representative \[LAR\] is acceptable)
- Are expected to live long enough to receive a VAP diagnosis, at the discretion of the treating clinician
- Are able to provide study-required biological samples
Exclusion
- Have a witnessed or suspected aspiration event prompting the need for current, new intubation
- Have known active lung cancer or metastatic disease to a lung
- Received a lung transplant
- Have cystic fibrosis
- Are receiving comfort care
- Are receiving antibiotic treatment for suspected or proven active acute bacterial infection (eg, pneumonia, tracheobronchitis, sepsis)
- Have a current or within-the-last-30-days diagnosis of active bacterial pneumonia
- Were previously enrolled in this trial
- Require long-term ventilator support
- Have a tracheostomy tube in place
- Are currently participating in an interventional drug or device study.
Key Trial Info
Start Date :
April 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06181669
Start Date
April 12 2024
End Date
December 30 2025
Last Update
September 18 2025
Active Locations (4)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Corewell (William Beaumont)
Royal Oak, Michigan, United States, 48073
3
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213