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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT05758506
Eligibility Criteria:
Inclusion Criteria:
* Aged 3 months to 15 years
* Presents for care at 1 of 9tertiary hospitals participating in the study
* Potential PID+ (Case): Child is identified by HCW to have \>2 Jeffrey Model warning signs of PID. \[Note: Upon immunology panel testing, this group will be separated into three categories: PID-, PID+, and PID+/PAD+ meaning they have 1 of 5 relevant primary antibody deficiencies (PAD+)\].
* PID-(Control): Child is identified (by snowball sampling) as being in good health, and having the same age (within 12 months) as another child who produced a PID+ result.
* Caregiver consents to participate in the study and provides informed consent. If their children are 10 years of age or older, that child must also give assent.
Exclusion Criteria:
* Aged less than 3 months or greater than 15 years of age
* Caregiver does not consent to participate, or child \>10years does not give assent to participate.
* Having received IVIG in the past 90 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
15 Years
Study:
NCT05758506
Study Brief:
Protocol Section:
NCT05758506