An observational study in Pneumonia, Bacterial and Ventilator Associated Pneumonia, sponsored by Duke University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Duke University · Observational
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.
This is a prospective, observational, diagnostic, feasibility study to determine the accuracy of pathogen- and host-directed testing for the diagnosis of VAP. Newly intubated adult patients admitted to the ICU will be assessed for eligibility around the time of intubation according to the inclusion/exclusion criteria. Screening and consent can occur any time within 48 hours of a patient being intubated. Between 48 and 60 hours after intubation, eligible participants will have blood drawn and dedicated research aliquots from SOC ETS samples retrieved. The dedicated research aliquots from SOC ETS samples will be obtained simultaneously with routine sampling for microbiologic testing or, when this is not possible, during routine suctioning as a part of standard airway care. Collection of other clinical data may occur 24 to 72 hours after intubation.
Participants will be followed daily for a clinical change for up to 14 days from the time of intubation. Clinical change is defined as a clinical suspicion of new-onset VAP that prompts the collection of lower respiratory tract secretions for routine microbiologic testing and initiation, continuation, or modification of antibiotic therapy for a pneumonia indication.
Participants who experience a clinical change will have additional blood samples drawn and dedicated aliquots of the sample retrieved from standard-of-care ETS procedures. Additionally, if available, leftover bronchoalveolar lavage (BAL) will be reclaimed, and respiratory and blood bacterial isolates will be obtained from SOC cultures. Participants will be followed through the diagnosis of clinical change and finalization of all local microbiological and radiological results obtained as a part of usual care. Clinical data will be recorded through medical record review.
Participants who do not experience a clinical change will be followed through extubation, ICU discharge, death, or for up to 14 days after intubation - whichever comes first. Participants who do not have a clinical change will not undergo additional sample collection.
Clinical change events will be used to assess whether the participant meets the clinical case definition (FDA criteria) for VAP: VAP-positive (VAP+) or VAP-negative (VAP-) categories will be obtained by an algorithm linked to the eCRF data. The VAP clinical case definition will be adjudicated against the participants' clinical data and microbiological evidence and the certainty of the VAP diagnosis will be classified as follows: Prove, Probable, Possible VAP, or No VAP. Every participant with a clinical change will be assessed for the presence of an extrapulmonary infection. Extrapulmonary infection will be classified as follows: Proven, Possible, or No Infection.
Evaluable participant specimens will be sent to a central laboratory for distribution to the testing centers that will perform the index testing. This study will compare pathogen-directed tests and 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 centers will be blinded to whether the samples were collected at baseline or clinical change. Neither the study sites, participants, nor adjudicators will receive the results from the index testing.
156 studies on the registry are indexed under Pneumonia, Bacterial; 19 are open to participants now.
This study's enrollment of 173 is below the median of 257 across 39 observational studies indexed under Pneumonia, Bacterial.
Browse Pneumonia, Bacterial studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Intubated adult patients (≥18 years of age) admitted to the ICU will be assessed for eligibility around the time of intubation according to the inclusion/exclusion criteria. Screening and consent may occur at any time within 48 hours of patients being intubated. The target sample size is 250 participants in order to observe approximately 30 clinical VAP-positive cases. Vulnerable patients, including women and minorities, will be included in this study.
Exclusion Criteria:
There are no interventions in this study. Standard of care activities will be captured in the eCRF and samples will be collected and tested. Results will not be returned to the sites or participants.
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.
Also known as: Respiratory Pathogen ID/AMR Enrichment Panel (Illumina), Metagenomic Next Generation Sequencing (Illumina), T2 Bacteria Panel (T2 Biosystems), T2 Resistance Panel (T2 Biosystems), Procalcitonin (Abbott), TriVerity host (Inflammatix), Host gene expression, FilmArray Pneumonia Panel (BioFire)
The number of participants with positive results on the Respiratory Pathogen ID/AMR Enrichment Panel (Illumina)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: 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)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: 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)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: 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)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: Through study completion, or up to 18 months, whichever comes first
The number of participants with positive results on the Procalcitonin (Abbott)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: Through study completion, or up to 18 months, whichever comes first
The number of participants with positive results on the TriVerity host (Inflammatix)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: Through study completion, or up to 18 months, whichever comes first
The number of participants with positive results on the Host gene expression
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: Through study completion, or up to 18 months, whichever comes first
The number of participants with positive results on the FilmArray Pneumonia Panel (BioFire)
This study will compare the results (positive, negative, or no result) of each index test.
Time frame: Through study completion, or up to 18 months, whichever comes first
Number of participants with a clinical diagnosis of VAP at the time of clinical change
* Clinical diagnosis of VAP is defined as new findings in each category of signs and imaging o At least one of the following signs of inflammation: Fever \>=38 °C or =35 °C Leukocytosis (white blood cell count ≥12K/mm3 or ≤4K/mm3) \>15% immature neutrophils (bands) AND * signs of respiratory worsening. AND * New or progressive changes suggestive of bacterial pneumonia from imaging: infiltrate, consolidation, and/or cavitation * Clinical change is defined as a clinical suspicion of new onset VAP that prompts collection of lower respiratory tract secretions for routine microbiologic testing and initiation or continuation of empiric antibiotic therapy for a pneumonia indication.
Time frame: day 15
Number of participants with an adjudicated diagnosis of of proven, probable, possible, or no VAP at the time of clinical change utilizing clinical and microbiological information
\- clinical information collected from participants with a clinical change will be reviewed to discern the presence of signs and symptoms of VAP as well as evidence of extrapulmonary infection. Cases of suspected VAP and extra-pulmonary infection will then be classified as proven, probable/possible or no infection using expert adjudication and standardized definitions.
Time frame: through extubation, ICU discharge, death, or for up to 14 days after intubation - whichever comes first
Plan to share: Yes — During the analysis process, diagnostic companies will support the testing of some specimens and will provide the resulting data back to the Duke Clinical Research Institute. Once clinical and laboratory data have been analyzed and the primary manuscript has been published, investigators may apply to the Antibacterial Resistance Leadership Group (ARLG) for use of data. Continued regulatory oversight, Data Use Agreements, and Material Transfer agreements may apply.
Supporting information: Study protocol
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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