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Project Summary/Abstract
The Personalized Immunomodulation in Pediatric Sepsis-induced MODS (PRECISE) study that is currently
being conducted by the NICHD’s Collaborative Pediatric Critical Care Research Network (CPCCRN) uses real-
time immune phenotyping to assign subjects to treatment or observational cohorts based on their immune
status. The 24-site, 1000-subject PRECISE study currently uses the whole blood ex vivo LPS-induced TNFα
production capacity (TNFα response) assay to diagnose severe innate immune suppression, termed
“immunoparalysis”. An alternative approach to diagnosing immunoparalysis is the measurement of the
expression of the antigen-presenting molecule HLA-DR on the surface of circulating monocytes (mHLA-DR)
using flow cytometry. The current application proposes the addition of mHLA-DR expression measurement,
which is now much more feasible for multi-center use than at the time of the original study design, to the
PRECISE immunophenotyping panel. Though mHLA-DR expression will not be used to drive cohort
assignment, its addition will allow for the evaluation of mHLA-DR expression as a potential diagnostic tool that
could drive treatment in the future. This is important because there are currently no FDA-approved laboratory
tests for the diagnosis of immunoparalysis, and if the PRECISE study is positive, there is currently no way to
rapidly generalize its results. The addition of mHLA-DR expression to the dataset provides a unique and time-
limited opportunity to understand if thresholds of mHLA-DR expression exist that equate to the TNFα response
cutoff used in the PRECISE study; and to understand if mHLA-DR expression can serve as a predictor of a
favorable response to GM-CSF. If positive, this could greatly accelerate the movement of immunoparalysis
diagnostics to the clinical laboratory, to the benefit of critically ill children.
Status | Active |
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Effective start/end date | 8/13/21 → 7/31/24 |
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Collaborative Pediatric Critical Care Research Network - Clinical Site
Eunice Kennedy Shriver National Institute of Child Health and Human Development
8/1/23 → 7/31/24
Project: Research project
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Collaborative Pediatric Critical Care Research Network - Clinical Site
National Institute of Child Health and Human Development
7/1/21 → 7/31/23
Project: Research project