Sepsis Clinical Trial
Official title:
Molecular Diagnosis and Risk Stratification of Sepsis
Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools
available to the clinician to initiate therapy of patients with sepsis mainly comprise of
symptom classification systems and culture techniques, which provide aspecific and slow
information.
Objective: The ultimate goal of this program is to assist the physician at the bedside in
tailoring the treatment of an individual patient suffering from sepsis by generating rapid
molecular information about the causative pathogen and the host response.
Deliverables: Rapid tests ("sample-in-result-out") that can be used by health care personnel
at or close to the bedside and that provide rapid information (within two hours) about the
presence or absence of sepsis, the causative pathogen and the risk of the individual patient
for sepsis complications and death.
Design: The program is organized into four Work Packages (WPs) along a clinical, discovery
and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted
to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these
patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from
these patients will be used to develop rapid, fully automated DNA-based bedside tests that
identify microorganisms and also provide information about their resistance to antibiotics.
In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and
to develop rapid and easy to perform tests that provide information about the risk profile
of the patient. In addition, plasma levels of selected protein biomarkers will be measured
for comparison of their value with that of the identified leukocyte molecular signatures.
WP4 is responsible for the ICT management of the project. The Clinical Platform (covered by
WP1 and WP4) delivers patient data and biological samples to the discovery and technology
platforms. The Discovery Platform (covered by WP2 and WP3) uses patient data and biological
samples to develop tests for detection of the infectious agent causing sepsis and for
stratification of patients according to their risk for sepsis complications, including
death. The results generated within the discovery platform will be delivered to the
technology platform. The Technology Platform (part of WP2 and WP3) has the specific aim to
develop rapid assays that run on a fully automated (micro)fluidics platform that is so easy
to operate that it can be used in decentralized settings such as (close to) the ICU. The
developed assays will make use of the knowledge generated in the discovery platform.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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