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

Tuberculosis Clinical Trial

— IQ  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973970
• Other study ID #: US TX 153
• Status: Completed
• Start date: September 23, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Oxford Immunotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
United States	University of Texas Health	Brownsville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Immunotec

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NTBSLR	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.	2 year
Secondary	IGRA	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).	2 year