Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
Primary Purpose
Toxoplasma Infections
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
toxoplasma ICT IgG-IgM BK
Sponsored by
About this trial
This is an interventional diagnostic trial for Toxoplasma Infections focused on measuring toxoplasma, test, feasibility
Eligibility Criteria
Inclusion Criteria:
- any adult who is willing to participate in the study
Exclusion Criteria:
- no
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single group
Arm Description
binary: positive or negative result
Outcomes
Primary Outcome Measures
congruence of Toxoplasma ICT IgG-IgM test and standard predicate test
Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04474132
Brief Title
Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
Official Title
Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 . We will use a standard FDA cleared test in all studies. The FDA has suggested that we submit a pre subQ for a 510K and dual CLIA waiver.
This allows us also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.
Detailed Description
This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard predicate test. These results will be provided to FDA for consideration for clearance of this test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxoplasma Infections
Keywords
toxoplasma, test, feasibility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
subjects are recruited continuously and being tested with the study device as well as with the standard cleared test for the presence of Toxoplasma gondii antibody.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single group
Arm Type
Other
Arm Description
binary: positive or negative result
Intervention Type
Device
Intervention Name(s)
toxoplasma ICT IgG-IgM BK
Intervention Description
a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody
Primary Outcome Measure Information:
Title
congruence of Toxoplasma ICT IgG-IgM test and standard predicate test
Description
Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test
Time Frame
two weeks for initial result and a year for whole study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
any adult who is willing to participate in the study
Exclusion Criteria:
no
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rima McLeod, M.D.
Phone
7738344130
Email
rmcleod@uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Zhou, Ph.D.
Phone
7738344120
Email
yzhou@bsd.uchicago.edu
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rima McLeod, M.D.
Phone
773-834-4130
Email
rmcleod@uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ying Zhou, Ph.D.
Phone
7738344120
Email
yzhou@bsd.uchicago.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30114251
Citation
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.
Results Reference
result
PubMed Identifier
28650970
Citation
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.
Results Reference
result
PubMed Identifier
30393749
Citation
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.
Results Reference
result
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Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
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