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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT06985160
Eligibility Criteria:
Inclusion Criteria:
* Infants aged between 1 day and 90 days (under 3 months)
* Hospitalized for evaluation of suspected invasive bacterial infections
* Informed consent obtained from parent(s) or legal guardian(s)
* Blood, urine, cerebrospinal fluid (CSF), or stool samples collected within 72 hours of admission
* Genetic material (blood sample) available for DNA extraction
Exclusion Criteria:
* Known or suspected congenital immunodeficiency
* Previous diagnosis of genetic syndromes affecting immune function
* Major congenital anomalies or chromosomal abnormalities
* Antibiotic therapy initiated more than 24 hours before sample collection
* Parental refusal to participate or withdraw consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
3 Months
Study:
NCT06985160
Study Brief:
Protocol Section:
NCT06985160