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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05621876
Other study ID # 1923231
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date September 30, 2024

Study information

Verified date March 2024
Source PATH
Contact Megan Parker
Phone 202.460.6239
Email mparker@path.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 30, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria: - Must be 6 months of age. - The types of PID presenting for IV-Ig therapy will include Evaluation of PID RDT with human capillary blood (version 1.0) | 8agammaglobulinemia (AG), hypogammaglobulinemia (HAG), common variable immunodeficiency (CVID), and hyper IgM syndrome (HIGM). Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
IgG deficiency rapid screening test
We will be testing patients who have already been diagnossed iwth primary immunodeficiency (PID) disease. there are 400 types of PID. We will test their blood before they receive antibody transfusion to evaluate the accuracy of our new screening test. We are trying to develop easy to use, low-cost screening tests for doctors to use with patients to detect those with low IgG levels before they are given the oral polio vaccine. These patients must be prioritized for intramuscular injections of a polio vaccine to prevent potential spread of wild type polio.

Locations

Country Name City State
Tunisia National Bone Marrow Transplant center Tunis

Sponsors (4)

Lead Sponsor Collaborator
PATH Bill and Melinda Gates Foundation, Centre National de Greffe de Moelle Osseuse, Institut Pasteur de Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluateusability among end users of the PID rapid screening tests using capillary blood samples obtained from PID patients, prior to receipt of IV-Ig treatment. - Did the test run correctly when following the IFU?
•Was the end user (nurse) able to interpret a test result for the patient from the investigational PID RDT (positive, negative) with valid control using a patient's capillary finger prick sample?
3 month
Primary To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma). What is the % agreement between the PID RDT run on capillary blood (Capillary Test A) and the referent assay run on plasma/serum? 3 months
Secondary To determinethe utility of the PID RDTwith PID patients. Can the investigational PID RDT be used with a finger prick (capillary) blood sample among study participants?
Was the finger prick blood sample successfully collected from the finger and transferred to the PID RDT?•Did the test run complete and give a valid result when run according to instructions?
Could a result be interpreted from the PID RDT?
3 months
Secondary To determine% agreement between capillary and venous blood samples using the PID RDT What is the % agreement between fresh capillary blood and fresh venous blood using the PID RDT? 3 months
See also
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