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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT04690569
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian and assent from the patient (depending on the local requirements)
* Over 90 days of age
* Clinical suspicion of acute bacterial or viral infection
* Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days
* Current disease duration ≤ 7 days
Exclusion Criteria:
* Another unrelated episode of febrile infection within the past 2 weeks
* Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis
* \>48 hours of oral antibiotic treatment
* \>12 hours of intravenous\\intramuscular antibiotic treatment
* HIV, HBV, or HCV infection (self-declared or known from medical records)
* A proven or suspected infection on presentation with Mycobacterial (e.g. Tuberculosis, MAC), parasitic or fungal (e.g. Candida, Histoplasma, Aspergillus) pathogen
* Active inflammatory disease (e.g. IBD, SLE, JIA, RA, Kawasaki, other vasculitis)
* Major trauma and\\or burns in the last 7 days
* Major surgery in the last 7 days
* Congenital immune deficiency (CID)
* Acquired immune deficiency\\modulation state including:
* Active malignancy
* Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
* Administration of P.O.\\IV\\IM high dose steroids \>1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids \> 0.25 mg/kg/day in the past 7 days
* Monoclonal antibodies, anti-TNF agents
* Intravenous immunoglobulin (IVIG)
* Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
* G/GM-CSF, Interferons
* Post solid organ/bone marrow transplant patients
* Asplenia, sickle cell disease
* Indwelling central venous catheter
* Cystic Fibrosis
* Pregnancy- self reported or medically known
* Other severe illnesses that affect life expectancy and quality of life such as:
* Severe psychomotor retardation
* Congenital metabolic disorder
* End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
90 Days
Study:
NCT04690569
Study Brief:
Protocol Section:
NCT04690569