Status:
COMPLETED
Performance Evaluation of the VIDAS TB-IGRA Assay.
Lead Sponsor:
BioMérieux
Conditions:
Active Tuberculosis
Latent Tuberculosis Infection
Eligibility:
All Genders
2+ years
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 stud...
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 c...
Eligibility Criteria
Inclusion
- Active TB Population
- 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
- 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
Key Trial Info
Start Date :
December 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
2401 Patients enrolled
Trial Details
Trial ID
NCT04048018
Start Date
December 5 2019
End Date
June 30 2021
Last Update
July 16 2021
Active Locations (24)
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1
Stanford University
Palo Alto, California, United States, 94304
2
UC San Diego
San Diego, California, United States, 92103
3
Naional Jewish Health
Denver, Colorado, United States, 80206
4
University of Florida
Gainesville, Florida, United States, 32610