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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03929705

Acronym

Enrollment

676

Registered

2019-04-29

Start date

2019-05-02

Completion date

2020-01-23

Last updated

2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis (TB)

Keywords

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
T-Spot	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.

Countries

South Africa

Outcome results