250
Participants
Start Date
April 12, 2024
Primary Completion Date
July 3, 2025
Study Completion Date
December 30, 2025
Pathogen and Host Directed testing
"This study will compare up to 6 pathogen-directed tests and 3 host biomarker tests. Pathogen-directed tests detect and identify the most common causes of bacterial pneumonia, while host biomarker tests assess the host's immune response to infection. Testing will occur at various testing centers.~Evaluable participant specimens will be sent to a central laboratory for distribution to the testing centers that will perform the index testing. Testing centers will be blinded to whether the samples were collected at baseline or clinical change. Further, each testing center will prepare and test the specimens according to documented procedures, then transfer the testing results to the ARLG Statistics and Data Management Center for analysis. Neither the study sites, participants, nor adjudicators will receive the results from the index testing. After the study, untested aliquots of specimens will be stored in the ARLG Physical Biorepository."
University of Pittsburgh Medical Center, Pittsburgh
Corewell (William Beaumont), Royal Oak
Henry Ford Hospital, Detroit
Washington University School of Medicine in St. Louis, St Louis
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Duke University
OTHER