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

NCT01917461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1001

Last updated 2016-03-08

No results posted yet for this study

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

Sponsors & Collaborators

  • MeMed Diagnostics Ltd.

    lead INDUSTRY

Principal Investigators

  • Kfir Oved, Dr. · MeMed Diagnostics Ltd.

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-12-31
Completion
2014-09-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917461 on ClinicalTrials.gov