Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:48 PM
Ignite Modification Date:
2025-12-24 @ 12:48 PM
NCT ID:
NCT01917461
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT01917461
Study Brief:
Protocol Section:
NCT01917461