Researchers at Henry M. Jackson Foundation (HJF) have developed diagnostic tools to predict severe sepsis or the risk of developing severe sepsis prior to the onset of any measurable symptoms. As sepsis mortality is known to increase with delay in anti-microbial administration, this predictive model can give clinicians lead time to plan and execute treatment protocols. Based on topological and clustering analysis of specific host biomolecular signatures, this model further helps identify phenotypes and stratify sepsis patients to develop an efficient treatment.

Applications and Advantages

• Point-of-Care decisions: This tool can be applied in low-resource, non-clinical locations such as military operation sites and home to determine and/or monitor if patients are at risk for developing sepsis and/or severity of sepsis-prior to the onset of measurable symptoms
• Triage decisions: In comparison to existing diagnostic methods, it provides clinicians with quick information to enable required rapid decision-making as septic patients can swiftly decline.
• Treatment decisions: Septic patient phenotypic modeling, along with input of patient clinical and specific biomarker data assist clinicians in developing personalized treatment plans.

Innovation Description

Sepsis is life-threatening organ dysfunction caused by dysregulated host response to infection. Sepsis or infections that cause sepsis, begin prior to hospital admission in nearly 87% of cases. Initial evaluation of sepsis includes basic blood tests, cultures, and imaging-all of which lack sensitivity and are time-consuming. Early detection of sepsis is a challenge as patients may present differences in severity of disease, etiology of disease as well the type and degree of Multiple Organ Dysfunction syndrome (MOD).

Factors affecting host responses in sepsis can be pathogen related and/or immune cell mediated. Such heterogeneity adds to the complexity of early clinical diagnosis. The model and resulting diagnostics developed by HJF scientists help predict if a patient is likely to develop sepsis and/or severity of sepsis prior to detection of any measurable symptoms (Fig.1). With the input of patient clinical parameters and specific biomarker data in this highly informative model, clinicians can quickly determine phenotypes to develop an effective treatment plan or correct course, if necessary to increase positive patient outcomes. As the model can be used in low-resource settings such as military environments and homes, these predictions could significantly increase the lead time for planning and execution of treatment protocols.

Inventors

• Danielle Clark, Ph.D., HJF
• Joost Brandsma, Ph.D. HJF
• Deborah Striegel, Ph.D., HJF
• Rittal Mehta, HJF

Innovation Status

Proof-of-feasibility for all biomarkers was demonstrated on septic and healthy patient cohort. Please see BioSensors and Bioelectronics. 2022 May; 10:100144

Intellectual Property Status

Patent applications have been filed in the U.S. (17/757,984), Australia (2020411504), Canada (3,163,000), Israel (294285), Japan (2022-539379), and Europe (20906754.5).