Clinical trial NCT04048018: Performance Evaluation of the VIDAS TB-IGRA Assay.
Official title: Performance Evaluation of the VIDAS TB-IGRA Assay.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Active Tuberculosis
Latent Tuberculosis Infection
Non-Tuberculous Mycobacterial (NTM) Pneumonia
Keywords: Interferon Gamma Release Assay
Tuberculosis
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 2401
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll persons with low to high risk factors for acquiring TB infection, persons with active TB disease, and persons with other types of Mycobacterial infections

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive, negative, indeterminate for tuberculosis
timeFrame: One-time measurement through study completion for each participant, an average of 5 months.
measure: Sensitivity and positive and negative percent agreement for the VIDAS TB IGRA assay with comparator assay
timeFrame: One-time measurement through study completion for each participant, an average of 5 months.
measure: Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay
timeFrame: One-time measurement through study completion for each participant, an average of 5 months.
measure: Measurement Precision of the VIDAS TB IGRA assay results
timeFrame: Triplicate measurement per sample through study completion, an average of 5 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Denver
country: United States
facility: Naional Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Illinois- Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: Campo Grande
country: Brazil
facility: Universidade Federal de Mato Grosso do Sul (UFMS)
city: Dourados
country: Brazil
facility: Universidade Federal Da Grande Dourados (UFGD)
city: Chambéry
country: France
facility: Anti-TB center of Chambéry
city: Montpellier
country: France
facility: Lapeyronie Hospital
city: Nanterre Cedex
country: France
facility: Anti-TB center of Nanterre
city: Paris
country: France
facility: Avicenne Hospital
city: Paris
country: France
facility: Lariboisière Hospital
city: Saint-Étienne
country: France
facility: North Hospital
city: Tbilisi
country: Georgia
facility: National Center for Tuberculosis and Lung Disease
city: Mumbai
country: India
facility: Hinduja Hospital
city: Rome
country: Italy
facility: INMI L. Spallanzani
city: Mexicali
country: Mexico
facility: Autonomous University of Baja California
city: Cape Town
country: South Africa
facility: TASK Applied Science, Delft Day Hospital Premises
city: South Africa
country: South Africa
facility: University of Cape Town Centre for Lung Infection and Immunity
city: London
country: United Kingdom
facility: Evelina London Children's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: UC San Diego
name: David Pride
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Maria Gennaro
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Michael Lauzardo
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Niaz Banaei
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois Chicago
name: Nahed Ismail
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Daniel Hoft
role: PRINCIPAL_INVESTIGATOR
affiliation: National Jewish Health
name: Charles Daley
role: PRINCIPAL_INVESTIGATOR
affiliation: Lariboisière Hospital
name: Amanda Lopes
role: PRINCIPAL_INVESTIGATOR
affiliation: Avicenne Hospital
name: Frederic Méchaï
role: PRINCIPAL_INVESTIGATOR
affiliation: Antoine-Béclère Hospital
name: Florence Doucet-Populaire
role: PRINCIPAL_INVESTIGATOR
affiliation: North Hospital
name: Elisabeth Botelho-Nevers
role: PRINCIPAL_INVESTIGATOR
References: