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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT06379061
Eligibility Criteria:
Inclusion Criteria:
* 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:
* Previously enrolled
* Insufficient sample volumes obtained
* For the adult and pediatric populations, \< 1.2 mL serum volume
* Sample handling errors
* 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
* Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (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., Inflammatory Bowel Disease \[IBD\], Systemic Lupus Erythematosus \[SLE\], Juvenile Idiopathic Arthritis \[JIA\], Rheumatoid Arthritis \[RA\], 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
1. Active malignancy treated within last 6 months
2. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
i. 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 ii. Monoclonal antibodies, anti-TNF agents iii. Intravenous immunoglobulin (IVIG) iv. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate v. G/GM-CSF Interferons c. Post solid organ/bone marrow transplant patients d. 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:
1. Severe psychomotor retardation
2. Congenital metabolic disorder
3. End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
90 Days
Maximum Age:
89 Years
Study:
NCT06379061
Study Brief:
Protocol Section:
NCT06379061