Point of Care Testing for Toxoplasmosis

Overseen By Rima McLeod, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Pregnancy 17-27 weeks

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications, so it's unclear. It's best to ask the trial organizers for more details.

What data supports the effectiveness of the treatment Toxoplasma ICT IgG-IgM BK for toxoplasmosis?

The Toxoplasma ICT IgG-IgM test has shown high sensitivity and specificity in detecting Toxoplasma antibodies, making it effective for diagnosing toxoplasmosis. This test is particularly useful in immunocompromised patients, where it provides reliable results quickly and easily. ^{1 2 3 4 5}

Is the point of care testing for toxoplasmosis safe for humans?

The research on bumped kinase inhibitors (BKIs), which may be related to the treatment you're asking about, shows that they have been tested for safety in animals. Some studies noted potential heart-related side effects, but further testing was done to minimize these risks. ^{6 7 8 9 10}

How does the point-of-care testing for toxoplasmosis differ from other treatments?

The point-of-care testing for toxoplasmosis is unique because it offers a quick and reliable way to detect specific antibodies (proteins made by the immune system) against the Toxoplasma parasite directly at the site of care, unlike traditional methods that require sending samples to a lab. This test is particularly useful for immunocompromised patients and can distinguish between different types of antibodies, providing immediate results that can guide further testing if needed. ^{1 4 5 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is open to any adult willing to participate. It's designed for those who may have been exposed to Toxoplasmosis, a common infection usually caught from cats or contaminated food.

Inclusion Criteria

I am an adult willing to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo testing using the Toxoplasma ICT IgG-IgM BK test and the standard predicate test

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

1 year

Treatment Details

Interventions

• toxoplasma ICT IgG-IgM BK

Trial Overview The study is testing the Toxoplasma ICT IgG-IgM BK, a new point of care test that checks for current or past T. Gondii infections against standard FDA cleared tests using blood samples from volunteers.

Participant Groups

Group I: single group Experimental Treatment 1 Intervention

binary: positive or negative result

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prevalence of latent toxoplasmosis and serological diagnosis of active infection in HIV-positive patients. [2019]

2. France pubmed.ncbi.nlm.nih.gov

Performance of seven commercial automated assays for the detection of low levels of anti-Toxoplasma IgG in French immunocompromised patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Vitros ECiQ immunodiagnostic system for detection of anti-Toxoplasma immunoglobulin G and immunoglobulin M antibodies for confirmatory testing for acute Toxoplasma gondii infection in pregnant women. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a New Immunochromatography Technology Test (LDBio Diagnostics) To Detect Toxoplasma IgG and IgM: Comparison with the Routine Architect Technique. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Performances of ICT Toxoplasma IgG-IgM test in comparison with Vidas® toxo competition to determine the immune status against Toxoplasma gondii. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of rat urinary kinin as bradykinin. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Acute and chronic actions of bradykinin on renal function and arterial pressure. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Bumped-Kinase Inhibitors for Cryptosporidiosis Therapy. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A short-term treatment with BKI-1294 does not protect foetuses from sheep experimentally infected with Neospora caninum tachyzoites during pregnancy. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Preparation of polyclonal antiserum against beta subunit of rabbit BK channel]. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. [2022]

12. Ukraine pubmed.ncbi.nlm.nih.gov

[Diagnostic significance of tests with toxoplasmin in clinical practice]. [2016]