Performance Evaluation of the VIDAS TB-IGRA Assay.

Latent Tuberculosis Infection Clinical Trial

Official title:

Performance Evaluation of the VIDAS TB-IGRA Assay.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048018
• Other study ID #: B2694-CTPR
• Status: Completed
• Start date: December 5, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.

Description:

Tuberculosis (TB) infection is one of the top 10 causes of death in the world and the leading cause of death due to a single infectious agent. Millions of people are infected with TB each year which can pose significant economic and health care burdens on the global population.

TB can infected the lungs (pulmonary TB) or other organs such as the brain, and kidneys (extra-pulmonary TB). When a person with pulmonary TB coughs or sneezes, water droplets containing M. tuberculosis are expelled into the air. Persons can become infected with TB when they inhale air containing these water droplets, however, not everyone infected with Mycobacterium tuberculosis (Mtb) becomes ill. Therefore two TB-related conditions exist: latent TB infection (LTBI) and TB disease.

People with latent TB infection are not ill and do not present TB symptoms or have TB disease. The only sign of TB infection is a positive reaction to the tuberculin skin test or TB blood tests such as IGRA tests. People with latent TB infection are not contagious and cannot spread TB infection to others.

Identification and treatment of LTBI can substantially reduce the risk of developing active disease. However, there is no diagnostic gold standard for LTBI. Two types of test are currently available for the identification of LTBI: the tuberculin skin test (TST) and the TB Interferon Gamma (IFN-γ) Release Assay (TB-IGRA). Evidence suggests that both TST and TB-IGRA are acceptable but not perfect because they detect indirect markers of Mtb exposure and indicate a cellular immune response to M. tuberculosis. TB-IGRAs have a number of advantages compared to TST which promote their progressive adoption in the clinical practice and in guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2401
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Active TB Population

Inclusion Criteria:

A person classified as or suspected of having M. tuberculosis disease (active TB):

A person with known HIV status, determined by a laboratory or rapid test performed no earlier than one month prior to, or at the time of inclusion into this study A person of age = 2 years

Exclusion Criteria:

A person who has been on an anti-TB treatment for >15 days for the ongoing infection Pregnant women A person who has received an anti-tumor necrosis factor (TNF) alpha treatment within the previous 3 months A person who has had prior TST A person with an NTM infection A person with positive HIV status.

High Risk for TB infection

Inclusion criteria :

A person who is at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB:

A person with age = 2 years A person with known HIV status

Non-inclusion criteria will be:

A person who has or has had active TB A person who has received treatment for active TB or LTBI A person who has received an anti-TNF alpha treatment A person who has had a TST Pregnant women Person who has been an NTM infection

Low Risk for TB Infection

Inclusion criteria

Generally healthy people, unlikely to have encountered TB disease in the past, that may be subject to TB testing for professional, academic or personal reasons (e.g.: students, healthcare personnel and healthcare volunteers, military recruits) A person with age = 18 years old

Non-inclusion criteria A person who is considered at high risk for LTBI A person who has or has had active TB A person who has received treatment for active TB or LTBI A person who has received an anti-TNFalpha treatment A person who has had a TST Pregnant women A person who has been diagnosed with a NTM infection

NTM population:

Inclusion criteria A person who is positive for NTM of interest confirmed by culture and identification;

Non-inclusion criteria A person who has been on antibiotic treatment for NTM; A person with confirmed active TB; A person with HIV; A person with a history of active TB; A person who have received treatment for LTBI; A person who is at high risk for LTBI Pregnant women.

Precision Population

Inclusion criteria:

A person previously enrolled in the Active TB, High Risk or Low Risk studies, or a blood donor.

Non-inclusion criteria An adult who was not previously enrolled in the Active TB, High Risk or Low Risk studies except for blood donors

For blood donors only:

A person who can be classified as being at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB

Related Conditions & MeSH terms

• Active Tuberculosis
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Non-Tuberculous Mycobacterial (NTM) Pneumonia
• Pneumonia
• Tuberculosis

Intervention

Diagnostic Test:
• Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Mato Grosso do Sul (UFMS)	Campo Grande
Brazil	Universidade Federal Da Grande Dourados (UFGD)	Dourados
France	Anti-TB center of Chambéry	Chambéry
France	Lapeyronie Hospital	Montpellier
France	Anti-TB center of Nanterre	Nanterre Cedex
France	Avicenne Hospital	Paris
France	Lariboisière Hospital	Paris
France	North Hospital	Saint-Étienne
Georgia	National Center for Tuberculosis and Lung Disease	Tbilisi
India	Hinduja Hospital	Mumbai
Italy	INMI L. Spallanzani	Rome
Mexico	Autonomous University of Baja California	Mexicali
South Africa	TASK Applied Science, Delft Day Hospital Premises	Cape Town
South Africa	University of Cape Town Centre for Lung Infection and Immunity	South Africa
United Kingdom	Evelina London Children's Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	St Thomas' Hospital	London
United States	University of Illinois- Chicago	Chicago	Illinois
United States	Naional Jewish Health	Denver	Colorado
United States	University of Florida	Gainesville	Florida
United States	Rutgers University	Newark	New Jersey
United States	Stanford University	Palo Alto	California
United States	Saint Louis University	Saint Louis	Missouri
United States	UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Countries where clinical trial is conducted

United States,  Brazil,  France,  Georgia,  India,  Italy,  Mexico,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive, negative, indeterminate for tuberculosis	The VIDAS or comparator assays will qualitatively determine the presence or absence of Mycobacterial TB infection in a participant's blood. This measurement is based on the level of interferon gamma released after stimulation of T cells in blood.	One-time measurement through study completion for each participant, an average of 5 months.
Primary	Sensitivity and positive and negative percent agreement for the VIDAS TB IGRA assay with comparator assay	Results obtained using the VIDAS assay will be compared with the results obtained from other methods.	One-time measurement through study completion for each participant, an average of 5 months.
Primary	Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay	Persons with NTM will be tested using the VIDAS TB IGRA.	One-time measurement through study completion for each participant, an average of 5 months.
Primary	Measurement Precision of the VIDAS TB IGRA assay results	6- 4mL blood samples will be collected from each participant and tested using different VIDAS instruments.	Triplicate measurement per sample through study completion, an average of 5 months.