Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
NCT ID: NCT04474132
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2020-08-13
2026-08-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single group
binary: positive or negative result
toxoplasma ICT IgG-IgM BK
a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody
Interventions
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toxoplasma ICT IgG-IgM BK
a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Rima McLeod, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lykins J, Li X, Levigne P, Zhou Y, El Bissati K, Clouser F, Wallon M, Morel F, Leahy K, El Mansouri B, Siddiqui M, Leong N, Michalowski M, Irwin E, Goodall P, Ismail M, Christmas M, Adlaoui EB, Rhajaoui M, Barkat A, Cong H, Begeman IJ, Lai BS, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Peyron F, McLeod R. Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies. PLoS Negl Trop Dis. 2018 Aug 16;12(8):e0006536. doi: 10.1371/journal.pntd.0006536. eCollection 2018 Aug. No abstract available.
Begeman IJ, Lykins J, Zhou Y, Lai BS, Levigne P, El Bissati K, Boyer K, Withers S, Clouser F, Noble AG, Rabiah P, Swisher CN, Heydemann PT, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Stillwaggon E, Peyron F, McLeod R. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries. PLoS Negl Trop Dis. 2017 Jun 26;11(6):e0005670. doi: 10.1371/journal.pntd.0005670. eCollection 2017 Jun.
Gomez CA, Budvytyte LN, Press C, Zhou L, McLeod R, Maldonado Y, Montoya JG, Contopoulos-Ioannidis DG. Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. Open Forum Infect Dis. 2018 Oct 29;5(10):ofy215. doi: 10.1093/ofid/ofy215. eCollection 2018 Oct.
Zhou Y, Leahy K, Grose A, Lykins J, Siddiqui M, Leong N, Goodall P, Withers S, Ashi K, Schrantz S, Tesic V, Abeleda AP, Beavis K, Clouser F, Ismail M, Christmas M, Piarroux R, Limonne D, Chapey E, Abraham S, Baird I, Thibodeau J, Boyer KM, Torres E, Conrey S, Wang K, Staat MA, Back N, L'Ollivier C, Mahinc C, Flori P, Gomez-Marin J, Peyron F, Houze S, Wallon M, McLeod R. Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. PLoS Negl Trop Dis. 2024 May 28;18(5):e0011335. doi: 10.1371/journal.pntd.0011335. eCollection 2024 May.
Other Identifiers
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IRB20-0442
Identifier Type: -
Identifier Source: org_study_id
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