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OpenTrials
Completed

NCT Number: NCT03929705

Assessing the Ability of the T-SPOT®.TB Test

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.

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cape Town

Cape Town, 7925 ZA, South Africa

About this study

The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 680 subjects (based on previous enrolment rates of approximately 300-350 subjects enrolled for 50 active TB and 50 active TB excluded).

Study Duration: 6 months

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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.

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 TB Specific Lymphocyte Response

Acronym: IQ

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Oct 23, 2020

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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