Status:
COMPLETED
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections
Lead Sponsor:
MeMed Diagnostics Ltd.
Conditions:
LRTI
UTI
Eligibility:
All Genders
1+ years
Brief 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 b...
Eligibility Criteria
Inclusion
- Patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. For the infectious and non-infectious disease groups, additional inclusion criteria have to be met. These will include:
- In the Infectious disease group:
- Peak fever \>37.5°C (99.5°F)
- Clinical suspicion of an acute infectious disease
- Symptoms duration ≤ 12 days
- In the Non-infectious disease control group:
- \- A non-infectious disease or healthy individuals
Exclusion
- Patients who will meet one or more of the following criteria will be excluded from the study:
- Evidence of another episode of acute infectious disease in the last two weeks
- Diagnosed congenital immune deficiency (CID)
- Current treatment with immunosuppressive therapy such as: Active chemotherapy,Post-transplant drugs,High dose steroids (\>1 mg/kg/day prednisone or equivalent).
- Active radiotherapy
- Immune-modulating/suppressive drugs including monoclonal antibodies, intravenous immunoglobulin (IVIG), cyclosporine, and anti-TNF agents
- Current treatment with immune stimulants such as: Interleukin (IL)-2, Granulocyte-Monocytes/Granulocyte colony-stimulating factor (GM/G-CSF),Interferon.
- An active hematological malignancy
- A diagnosis of myelodysplastic syndrome or myeloproliferative disease
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT01917461
Start Date
September 1 2010
End Date
September 1 2014
Last Update
March 8 2016
Active Locations (2)
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1
Hillel Yaffe Hospital
Hadera, Israel, Israel, 38100
2
Bnei Zion Hospital
Haifa, Israel, Israel, 31048