Pneumonia Direct Pilot

Description

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 diagnosis of VAP versus an adjudicated clinical reference standard. The feasibility design is intended to inform future interventional studies that will investigate the clinical impact of combined pathogen- and host-directed testing approaches.

Conditions

Pneumonia, Bacterial, Ventilator Associated Pneumonia

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Study Overview

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Study Details

Study overview

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 diagnosis of VAP versus an adjudicated clinical reference standard. The feasibility design is intended to inform future interventional studies that will investigate the clinical impact of combined pathogen- and host-directed testing approaches.

Pneumonia Direct Pilot

Pneumonia Direct Pilot

Condition
Pneumonia, Bacterial
Intervention / Treatment

-

Contacts and Locations

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Royal Oak

Corewell (William Beaumont), Royal Oak, Michigan, United States, 48073

Saint Louis

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States, 63110

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Are ≥18 years old
  • 2. Are newly intubated for less than 48 hours and for reasons other than suspected bacterial pneumonia or suspected acute bacterial infection
  • 3. Are expected to require intubation for at least 48 hours, per the discretion of the treating clinician
  • 4. Are able to provide protocol-accepted consent (legally authorized representative \[LAR\] is acceptable)
  • 5. Are expected to live long enough to receive a VAP diagnosis, at the discretion of the treating clinician
  • 6. Are able to provide study-required biological samples
  • 1. Have a witnessed or suspected aspiration event prompting the need for current, new intubation
  • 2. Have known active lung cancer or metastatic disease to a lung
  • 3. Received a lung transplant
  • 4. Have cystic fibrosis
  • 5. Are receiving comfort care
  • 6. Are receiving antibiotic treatment for suspected or proven active acute bacterial infection (eg, pneumonia, tracheobronchitis, sepsis)
  • 7. Have a current or within-the-last-30-days diagnosis of active bacterial pneumonia
  • 8. Were previously enrolled in this trial
  • 9. Require long-term ventilator support
  • 10. Have a tracheostomy tube in place
  • 11. Are currently participating in an interventional drug or device study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Kimberly E Hanson, MD, MHS, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

2025-07-30