Status:
COMPLETED
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
Lead Sponsor:
MeMed Diagnostics Ltd.
Collaborating Sponsors:
Bnai Zion Medical Center
University Hospital, Geneva
Conditions:
Fever
Respiratory Tract Infections
Eligibility:
All Genders
1-18 years
Brief Summary
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The inv...
Eligibility Criteria
Inclusion
- The infectious disease samples should also fulfill the following criteria:
- The patient had a peak temperature ≥38°C (AND)
- Symptoms initiated ≤ 7 days before sampling
- The non-infectious disease control group will include:
- Patients with a non-infectious disease
Exclusion
- Another infection episode during the last 3 weeks before sampling
- Congenital immune deficiency (CID)
- A proven or suspected HIV-1, HBV, HCV infection
- Active hematological malignancy
- Current treatment with immune-suppressive or immune-modulating
- Other illnesses that affect life expectancy and/or quality of life
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01911143
Start Date
September 1 2013
End Date
August 1 2015
Last Update
March 8 2016
Active Locations (2)
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1
Hillel Yaffe Medical Center
Hadera, Israel
2
Bnai Zion Medical Center
Haifa, Israel