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NCT04474132 · ClinicalTrials.gov registry record · NA
Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
A NA study of Toxoplasma Infections, sponsored by University of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT04474132: Recruiting NA study of Toxoplasma Infections, sponsored by University of Chicago.
NCT04474132 is a NA study of Toxoplasma Infections that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 210 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04474132, a NA study of Toxoplasma Infections, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study Summary
This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant. This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver. This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.
Primary Outcome
Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test
Conditions Studied
Interventions
- DEVICE toxoplasma ICT IgG-IgM BK
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2026-08-20 |
| Phase | NA |
What NCT04474132 shows while recruiting
NCT04474132 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Toxoplasma Infections appearing as the primary indexed condition, and to 1 intervention - of which toxoplasma ICT IgG-IgM BK is the first listed.
NCT04474132 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04474132 about?
NCT04474132 is a clinical study titled "Point of Care Testing for Presence of Current and or Previous T. Gondii Infection". This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either p...
What is the current status of trial NCT04474132?
This trial is currently recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2020-08-13. Estimated completion is 2026-08-20.
What conditions does trial NCT04474132 study?
This clinical trial studies the following conditions: Toxoplasma Infections.
What interventions are being tested in trial NCT04474132?
The interventions under investigation include: toxoplasma ICT IgG-IgM BK (DEVICE).
Who is sponsoring clinical trial NCT04474132?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04474132 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04474132's enrollment target sits among peer trials
210 490th of 2000 higher than 1,505 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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