CompletedNot Applicable

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

United States173 participantsStarted 2024-04-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

The number of participants with positive results on the Respiratory Pathogen ID/AMR Enrichment Panel (Illumina)

Timeframe: Through study completion, or up to 18 months, whichever comes first

The number of participants with positive results on the Metagenomic Next Generation Sequencing (Illumina)

Timeframe: Through study completion, or up to 18 months, whichever comes first

The number of participants with positive results on the T2 Bacteria Panel (T2 Biosystems)

Timeframe: Through study completion, or up to 18 months, whichever comes first

The number of participants with positive results on the T2 Resistance Panel (T2 Biosystems)

Timeframe: Through study completion, or up to 18 months, whichever comes first

The number of participants with positive results on the Procalcitonin (Abbott)

Timeframe: Through study completion, or up to 18 months, whichever comes first

The number of participants with positive results on the TriVerity host (Inflammatix)

Timeframe: Through study completion, or up to 18 months, whichever comes first

The number of participants with positive results on the Host gene expression

Trial details

NCT IDNCT06181669

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-03

View on ClinicalTrials.gov More Pneumonia, Bacterial trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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