Active TuberculosisNCT04048018
Performance Evaluation of the VIDAS TB-IGRA Assay.
An observational study of Active Tuberculosis and Latent Tuberculosis Infection, run by BioMérieux at 24 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- What is being tested?
- Blood draw and IGRA test
- How many people
- 2,401 participants
- Where
- 24 sitesin 9 countries
- Study dates
- 5 Dec 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
- 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
Show all 17Show fewer
- Low Risk for TB Infection
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 9 countries.
24 sites in 9 countries
United States7 sites
University of Illinois- Chicago
Chicago, Illinois, 60612
Naional Jewish Health
Denver, Colorado, 80206
University of Florida
Gainesville, Florida, 32610
Rutgers University
Newark, New Jersey, 07103
Stanford University
Palo Alto, California, 94304
UC San Diego
San Diego, California, 92103
Saint Louis University
St Louis, Missouri, 63103
France6 sites
Anti-TB center of Chambéry
Chambéry
Lapeyronie Hospital
Montpellier
Anti-TB center of Nanterre
Nanterre
Avicenne Hospital
Paris
Lariboisière Hospital
Paris
North Hospital
Saint-Etienne
United Kingdom3 sites
Evelina London Children's Hospital
London
Royal Free Hospital
London
St Thomas' Hospital
London
Brazil2 sites
Universidade Federal de Mato Grosso do Sul (UFMS)
Campo Grande
Universidade Federal Da Grande Dourados (UFGD)
Dourados
South Africa2 sites
TASK Applied Science, Delft Day Hospital Premises
Cape Town
University of Cape Town Centre for Lung Infection and Immunity
South Africa
About this study
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.
Read the 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.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Being tested
- Blood draw and IGRA test
- Keywords
- Interferon Gamma Release Assay, Tuberculosis
- Medical subject headings
- Latent Tuberculosis, Pneumonia, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw and IGRA testDiagnostic test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
| Study group | Role | What they receive |
|---|---|---|
| Active Tuberculosis Patient | Not described Receives: Diagnostic Test: Blood draw and IGRA test | |
| High risk for LTBI Participant | Not described Receives: Diagnostic Test: Blood draw and IGRA test | |
| Low risk for prior TB infection Participant | Not described Receives: Diagnostic Test: Blood draw and IGRA test | |
| NTM patient | Not described Receives: Diagnostic Test: Blood draw and IGRA test | |
| Precision patient | Not described Receives: Diagnostic Test: Blood draw and IGRA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One-time measurement through study completion for each participant, an average of 5 months.
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.
Measured: One-time measurement through study completion for each participant, an average of 5 months.
Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay
Persons with NTM will be tested using the VIDAS TB IGRA.
Measured: One-time measurement through study completion for each participant, an average of 5 months.
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.
Measured: Triplicate measurement per sample through study completion, an average of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start5 Dec 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pride, Principal investigator, UC San DiegoMaria Gennaro, Principal investigator, Rutgers UniversityMichael Lauzardo, Principal investigator, University of FloridaNiaz Banaei, Principal investigator, Stanford UniversityNahed Ismail, Principal investigator, University of Illinois ChicagoDaniel Hoft, Principal investigator, St. Louis UniversityCharles Daley, Principal investigator, National Jewish HealthAmanda Lopes, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048018
- Sponsor's protocol ID
- B2694-CTPR
- Status last verified
- Jul 2021
- First submitted
- 2 Aug 2019
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the VIDAS TB-IGRA Assay.
- ClinicalTrials.gov ID
- NCT04048018
- Acronym / sponsor ID
- B2694-CTPR
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Keywords
- Interferon Gamma Release Assay, Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,401 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Active Tuberculosis Patient | – | Diagnostic Test: Blood draw and IGRA test |
| High risk for LTBI Participant | – | Diagnostic Test: Blood draw and IGRA test |
| Low risk for prior TB infection Participant | – | Diagnostic Test: Blood draw and IGRA test |
| NTM patient | – | Diagnostic Test: Blood draw and IGRA test |
| Precision patient | – | Diagnostic Test: Blood draw and IGRA test |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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
- 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
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw and IGRA testOne to two blood samples will be obtained from participants in all arms in order to conduct testing. | Diagnostic test | Active Tuberculosis Patient, High risk for LTBI Participant, Low risk for prior TB infection Participant, NTM patient, Precision patient |
Primary outcome
Positive, negative, indeterminate for tuberculosis
Time frame: One-time measurement through study completion for each participant, an average of 5 months.
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.
Sensitivity and positive and negative percent agreement for the VIDAS TB IGRA assay with comparator assay
Time frame: One-time measurement through study completion for each participant, an average of 5 months.
Results obtained using the VIDAS assay will be compared with the results obtained from other methods.
Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay
Time frame: One-time measurement through study completion for each participant, an average of 5 months.
Persons with NTM will be tested using the VIDAS TB IGRA.
Measurement Precision of the VIDAS TB IGRA assay results
Time frame: Triplicate measurement per sample through study completion, an average of 5 months.
6- 4mL blood samples will be collected from each participant and tested using different VIDAS instruments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Active Tuberculosis
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pride principal investigator
UC San Diego
Maria Gennaro principal investigator
Rutgers University
Michael Lauzardo principal investigator
University of Florida
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Active Tuberculosis and Latent Tuberculosis Infection, run by BioMérieux at 24 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, United Kingdom, Brazil, South Africa and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive, negative, indeterminate for tuberculosis (time frame: One-time measurement through study completion for each participant, an average of 5 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.