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Completed

NCT Number: NCT03973970

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Health

Brownsville, Texas, 78520, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. NTBSLR

    Time frame: 2 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 outcomes

  1. IGRA

    Time frame: 2 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).

Sponsors and collaborators

Lead sponsor

Oxford Immunotec

Industry

Registry information

Official study 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.

Acronym: IQ

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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