Gastroenteritis Clinical Trial
Official title:
Observational, Prospective Study to Evaluate Biomarkers as Indicators of Bacterial or Viral Infection During Acute Infectious Diseases
This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to
enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at
identifying individual biomarkers and constructing a multi-parametric diagnostic model,
whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh
cohort of patients.
A collection of clinical, radiological and laboratory data will be gathered in order to
establish a final diagnosis. Blood samples will be analyzed and the levels of approximately
700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements
respectively.
A final diagnosis will be determined based on a majority decision of a panel of three or
more independent physicians. Based on the final diagnosis, the accuracy of individual
biomarkers and combined sets of biomarkers for differentiating between distinct groups of
patients will be evaluated.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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