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NCT05758506
Developing a Screening Tool for Primary Immunodeficiency Disease (PID) in Pakistan
trial testing Primary Immunodeficiency (PID) Rapid Diagnostic Test (RDT) in Primary Immunodeficiency Diseases in 200 participants. Completed in 15 December 2024.
30 September 2024
Quick facts
| Lead sponsor | PATH |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 July 2024 |
| Primary completion | 30 September 2024 |
| Estimated completion | 15 December 2024 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Primary Immunodeficiency (PID) Rapid Diagnostic Test (RDT)
Conditions studied
- Primary Immunodeficiency Diseases — all drugs for Primary Immunodeficiency Diseases →
Sponsor
PATH — full company profile →
Who can join
Adults 3 Months to 15, any sex, with Primary Immunodeficiency Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Case-control diagnostic accuracy study with 130 potential pediatric PID+ (primary immunodeficiency) patients, and 100 age-matched, healthy controls (PID-). The potential PID+ participants will be recruited prospectively through 9 hospitals in Sindh and Punjab states or contacted via the PID surveillance registry developed by AKU Hospital's Polio Excretion in PID study to identify children with primary antibody deficiency (PAD+: a type of PID+); healthy, age-matched PID-participants will be recruited by snowball sampling. At the point of care, health care workers (HCWs) will collect capillary blood samples (0.1mL) to run the PID rapid screening test and reader on potential PID+ participants (identified by exhibiting \>2 of the Jeffrey Modell warning signs) and healthy, age-matched controls. All pediatric study participants will be sent to the hospital lab to have a confirmatory immunology panel (see 4.4.1 Diagnosing PID for the battery of tests) run on a serum/plasma sample to confirm their PID diagnosis (PID+/PAD-, PID+/PAD+, PID-); a 1.5uL aliquot of serum/plasma will simultaneously be used to run a PID rapid screening test by a laboratory technician (LT). HCWs and LTs will be blinded to true PID status. Blood and serum PID rapid screening test results will be compared to the confirmatory immunology panel to determine diagnostic accuracy. All clinical management of study participants will follow the standard of care for PID in Pakistan and will be based upon the immunology panel result. The HCWs and LTs administering the tests will be trained prior to the diagnostic accuracy test (see Objectives below) and will provide feedback on the tool post-training and post-use to assess usability, acceptability, and feasibility of integrating the test and digital reader into tertiary hospitals for the purpose of improved national PID surveillance, improved PID patient care, and polio eradication in Pakistan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05758506
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Primary Immunodeficiency Diseases
Currently open trials in the same condition.
- NCT07346859 — Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID) · Phase 3 · recruiting
- NCT05236764 — Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion · NA · active not recruiting
Other PATH trials
Trials by the same sponsor.
- NCT06895486 — Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation · Phase 2 · recruiting
- NCT06129916 — Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB · not yet recruiting
- NCT06879327 — Infant Malaria Vaccine Schedule Optimization · Phase 2 · recruiting
- NCT06137664 — Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines · Phase 1, PHASE2 · recruiting
- NCT05621876 — Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients i · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05758506 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PATH
- Last refreshed: 31 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05758506.
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