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NCT06181669

MASTERMIND-Pneumonia Study (Also Known as Pneumonia Direct Pilot)

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

The MASTERMIND-Pneumonia Study (also known as 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

173

Start Date

2024-04-12

Completion Date

2025-07-03

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

Locations (4)

Henry Ford Hospital

Detroit, Michigan, United States

Corewell (William Beaumont)

Royal Oak, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States