ACTIVE_NOT_RECRUITING

Pneumonia Direct Pilot

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Conditions

Pneumonia, BacterialVentilator Associated Pneumonia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pneumonia Direct Pilot

Quick Facts

Study Start:2024-04-12
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06181669

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Are ≥18 years old
  2. 2. Are newly intubated for less than 48 hours and for reasons other than suspected bacterial pneumonia or suspected acute bacterial infection
  3. 3. Are expected to require intubation for at least 48 hours, per the discretion of the treating clinician
  4. 4. Are able to provide protocol-accepted consent (legally authorized representative \[LAR\] is acceptable)
  5. 5. Are expected to live long enough to receive a VAP diagnosis, at the discretion of the treating clinician
  6. 6. Are able to provide study-required biological samples
  1. 1. Have a witnessed or suspected aspiration event prompting the need for current, new intubation
  2. 2. Have known active lung cancer or metastatic disease to a lung
  3. 3. Received a lung transplant
  4. 4. Have cystic fibrosis
  5. 5. Are receiving comfort care
  6. 6. Are receiving antibiotic treatment for suspected or proven active acute bacterial infection (eg, pneumonia, tracheobronchitis, sepsis)
  7. 7. Have a current or within-the-last-30-days diagnosis of active bacterial pneumonia
  8. 8. Were previously enrolled in this trial
  9. 9. Require long-term ventilator support
  10. 10. Have a tracheostomy tube in place
  11. 11. Are currently participating in an interventional drug or device study.

Contacts and Locations

Principal Investigator

Kimberly E Hanson, MD, MHS
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Henry Ford Hospital
Detroit, Michigan, 48202
United States
Corewell (William Beaumont)
Royal Oak, Michigan, 48073
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Duke University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-12
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-04-12
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pneumonia, Bacterial
  • Ventilator Associated Pneumonia