Developing a Screening Tool for Primary Immunodeficiency Disease (PID) in Pakistan

Launched by PATH · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on developing a new screening tool to help identify children with Primary Immunodeficiency Diseases (PID) in Pakistan. PID is a condition where the body’s immune system doesn't work properly, making it harder for children to fight off infections. The study will involve about 130 children suspected of having PID and 100 healthy children of the same age. Participants will be recruited from nine hospitals in Sindh and Punjab, and they will undergo a simple blood test to see if they have PID. The results from this quick screening test will be compared to more detailed lab tests to check how accurate the screening tool is.

To be eligible for the trial, children must be between 3 months and 15 years old, show two or more warning signs of PID, and have consent from their caregivers to participate. Healthy children will be matched by age to those suspected of having PID. Participants can expect to have a small blood sample taken for testing, which is a quick and straightforward process. The ultimate goal of this trial is to improve the detection of PID in children, enhance patient care, and contribute to efforts in eradicating polio in Pakistan.

Gender

ALL

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