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Assessing the Ability of the T-SPOT®.TB Test (IQ) (IQ)

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ClinicalTrials.gov Identifier: NCT03973970
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Oxford Immunotec

Brief Summary:
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

Condition or disease
Tuberculosis

Detailed Description:

This study will enroll up to 202 subjects (assumes 15 % exclusion/drop-out rate). The target number of subjects is 75 active TB (recruited from subjects presenting at TB clinics) and 100 active TB excluded (recruited from subjects in the community).

All subjects enrolled in this study will be men or women, aged 18 years or older.

Duration: 1 year


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Study Type : Observational
Estimated Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized Tuberculosis (TB) Specific Lymphocyte Response.
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tuberculosis

Group/Cohort
Test Arm 1- T-SPOT.TB assay
Test Arm 1: T-SPOT.TB test using density gradient isolation (Leucosep) For each subject recruited in the study, cells will be isolated using Leucosep Tubes and T-Cell Xtend reagent according to package insert. For each subject recruited in the study, the T-SPOT.TB assay will be run according to the assay package insert.
Test Arm 2-QuantiFERON-TB Gold Plus assay
Test Arm 2: QuantiFERON-TB Gold Plus For each subject recruited in the study, the QuantiFERON-TB Gold Plus (QFT-Plus) assay will be run according to the assay package insert.



Primary Outcome Measures :
  1. T Spot [ Time Frame: 1 year ]
    The primary objective of this study is to demonstrate performance of the normalized Tuberculosis (TB) specific lymphocyte response (NTBSLR) in identifying patients with active Tuberculosis (TB) disease.


Secondary Outcome Measures :
  1. T Spot [ Time Frame: 1 year ]
    The secondary exploratory objective is to demonstrate that active Tuberculosis (TB) cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based Interferon-Gamma Release Assay (IGRA).


Biospecimen Retention:   Samples Without DNA
Peripheral blood mononuclear cells (PBMCs) and plasma will be retained and stored at the Lung Infection and Immunity laboratory Biobank for 3 years


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and Female 18 years of age and older
Criteria

Subject Inclusion Criteria: Cohort 1A and 1B

  • Must be at least 18 years of age
  • Must be able to provide informed consent
  • Must be able to provide a minimum of 10 mL of whole blood at each visit
  • Must be T-SPOT.TB positive
  • First visit suspect TB subjects with no prior history of TB diagnosis Subject exclusion criteria: Cohort 1A and 1B
  • Negative in the T-SPOT.TB test
  • Previous or pre-existing confirmed TB diagnosis
  • On anti-TB treatment for less than 1 week*
  • Not meeting inclusion criteria

Subject inclusion criteria: Cohort 2A and 2B

  • Must be at least 18 years of age
  • Must be able to provide informed consent
  • Must be able to provide a minimum of 10 mL of whole blood at each visit
  • Must be T-SPOT.TB positive
  • No prior history of TB diagnosis

Subject exclusion criteria: Cohort 2A and 2B

  • Negative T-SPOT.TB test
  • Previous or pre-existing confirmed TB diagnosis
  • On anti-TB treatment
  • Symptoms of active TB
  • Not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973970


Contacts
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Contact: Maya Peltz 508-535-2406 mpeltz@oxfordimmunotec.com

Locations
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United States, Texas
University of Texas Health Not yet recruiting
Brownsville, Texas, United States, 78520
Contact: Marielena (Anette) Benavidez       Marielena.A.Benavidez@uth.tmc.edu   
Principal Investigator: Blanca Restrepo, MD         
Sponsors and Collaborators
Oxford Immunotec
Investigators
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Principal Investigator: Blanca Restrepo, MD UTHealth Houston, School of Public Health

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Responsible Party: Oxford Immunotec
ClinicalTrials.gov Identifier: NCT03973970     History of Changes
Other Study ID Numbers: US TX 153
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oxford Immunotec:
TB

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections