Most patients with necrotizing soft tissue infection (NSTI) develop sepsis, i.e. infection causing organ dysfunction. In the INFECT study 2/3 of the patients even develop septic shock. Rapid identification of the pathogens in the bloodstream will guide the use of effective antimicrobial treatment and contribute to limit the risk for adverse effects caused by empirical antimicrobial therapy.
Within WP7 – led by Austrian molecular diagnostics firm Cube Dx – a DNA based test for rapid identification of any of a broad range of pathogenic bacteria (7 genera and 45 species) or fungi (6 genera and 32 species) has been developed. Using a method of DNA enrichment and extraction from whole blood, it is for the first time possible to identify sepsis-causing microbes within as little as 3 hours from taking the blood sample. The test has been developed several iterations and has been clinically validated across several clinical laboratories across Europe.
Along with the novel diagnostic tool for early pathogen detection a test to characterize host response to infection and as well as treatment response has been developed. Starting from a proof of concept, a multiplexed immuno-test to monitor (currently) 13 inflammatory and organ specific biomarkers is now available. The testing is performed using 100µL of blood plasma and delivers quantitative results in as little as 20 minutes. Following the new sepsis definition (2016), which defines sepsis as an inappropriate host response and the presence of organ dysfunction, the focus during the development of the test has been not to restrict it to describe inflammation itself, but also to offer monitoring of biomarkers indicating organ dysfunctions, e.g. kidney failure, heart failure, impacts on the central nervous system and the status of coagulation. This monitoring will now be clinically validated with all the plasma samples collected during the enrolment phase and on-site as well. Beside stratification of patients, the test can add to “early warning system” monitoring, as it indicates deterioration of a patient at a molecular level.