Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia

• Sponsor: PATH (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05621876
• Collaborator: Bill and Melinda Gates Foundation (Other), Institut Pasteur de Tunis (Other), Centre National de Greffe de Moelle Osseuse (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Immunodeficiency Diseases	Device: IgG deficiency rapid screening test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of an IgG Deficiency Rapid Screening Test (RDT) With Human Capillary Samples: A Protocol to Generate RDT Performance Data in Primary Immunodeficiency Patients (PID)
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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. [3 month]

   - 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?

2. To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma). [3 months]

   What is the % agreement between the PID RDT run on capillary blood (Capillary Test A) and the referent assay run on plasma/serum?

Secondary Outcome Measures

1. To determinethe utility of the PID RDTwith PID patients. [3 months]

   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?

2. To determine% agreement between capillary and venous blood samples using the PID RDT [3 months]

   What is the % agreement between fresh capillary blood and fresh venous blood using the PID RDT?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Bone Marrow Transplant center	Tunis		Tunisia

Sponsors and Collaborators

• PATH
• Bill and Melinda Gates Foundation
• Institut Pasteur de Tunis
• Centre National de Greffe de Moelle Osseuse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Megan Parker, Senior Program Officer, PATH
• ClinicalTrials.gov Identifier: NCT05621876
• Other Study ID Numbers: 1923231
• First Posted: Nov 18, 2022
• Last Update Posted: Nov 18, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: IgG Deficiency; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Nov 18, 2022