NCT01917461

Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections

Observational, Prospective Study to Evaluate Biomarkers as Indicators of Bacterial or Viral Infection During Acute Infectious Diseases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,001 (actual)
• Sponsor: MeMed Diagnostics Ltd. · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

Summary

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.

Conditions

• LRTI
• UTI
• Gastroenteritis
• Systemic Infections/Bacteremia/Meningitis
• Fever Without Source

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-12-01
• Completion: 2014-09-01
• First posted: 2013-08-06
• Last updated: 2016-03-08

Locations

2 sites across 1 country: Israel