Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929705
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : May 22, 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 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 (TB)

Detailed Description:

The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 235 subjects (assumes 15 % exclusion/drop-out rate).

Study Duration: 6 months

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


Layout table for study information
Study Type : Observational
Estimated Enrollment : 235 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 TB Specific Lymphocyte Response
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tuberculosis

Group/Cohort
Test Arm 1- T-SPOT.TB assay
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
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: 6 month study ]
    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.


Biospecimen Retention:   Samples Without DNA
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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 (16mL for immunocompromised i.e. HIV+)
    • Must be T-SPOT.TB positive
    • First visit suspect TB subjects with no prior history of TB diagnosis 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 (16mL for immunocompromised i.e. HIV+)
    • Must be T-SPOT.TB positive
    • No prior history of TB diagnosis

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 more than 1 week*
    • Not meeting inclusion criteria 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): NCT03929705


Contacts
Layout table for location contacts
Contact: Maya Peltz 508-535-2406 mpeltz@oxfordimmunotec.com
Contact: Rick Competiello rcompetiello@oxfordimmunotec.com

Locations
Layout table for location information
South Africa
University of Cape Town Recruiting
Cape Town, South Africa, 7925 ZA
Contact: Keertan Dheda, PhD    +27 21 404 7654    keertan.dheda@uct.ac.za   
Contact: Ali Esmail, MD    +27 21 406 6229    A.Esmail@uct.ac.za   
Sponsors and Collaborators
Oxford Immunotec
Investigators
Layout table for investigator information
Principal Investigator: Keertan Dheda, PhD University of Cape Town

Layout table for additonal information
Responsible Party: Oxford Immunotec
ClinicalTrials.gov Identifier: NCT03929705     History of Changes
Other Study ID Numbers: AF SA 148
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Oxford Immunotec:
TB

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