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

Completed

Conditions studied: Pneumonia, Bacterial, Ventilator Associated Pneumonia

In brief

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.

Key facts

Study ID

NCT06181669

Run by

Duke University

People needed

173

Starts

2024-04-12

Expected to finish

2025-07-03

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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