Trials / Completed
CompletedNCT03929705
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 676 (actual)
- Sponsor
- Oxford Immunotec · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2019-05-02
- Primary completion
- 2020-01-23
- Completion
- 2020-01-23
- First posted
- 2019-04-29
- Last updated
- 2020-10-23
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT03929705. Inclusion in this directory is not an endorsement.