Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT04048018
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT04048018
Study Brief:
Protocol Section:
NCT04048018