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Safety of Preventive Treatment in People at risk for Tuberculosis

Study on the safety evaluation of latent tuberculosis treatment in high-risk groups for tuberculosis development

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011063
Enrollment
1370
Registered
2025-09-23
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged =19 years. (2) Individuals who fall under any of the following indications for latent tuberculosis infection (LTBI) testing. Contacts of patients with infectious tuberculosis People living with HIV Persons currently receiving, or scheduled to receive, immunosuppressive agents Patients scheduled for treatment with TNF antagonists, other biologic agents, or small-molecule inhibitors Individuals with spontaneously healed tuberculosis lesions on chest radiography Persons currently using, or scheduled to use, long-term systemic corticosteroids Patients with autoimmune diseases Patients with chronic kidney disease, including those on dialysis Patients with hematologic malignancies or solid tumors Patients with diabetes mellitus Individuals who have undergone, or are scheduled to undergo, gastrectomy Patients with chronic lung disease (e.g., COPD, asthma, occupational/environmental lung diseases) Individuals with infection documented within the past two years (i.e., documented conversion on LTBI testing) Healthcare workers Employees of congregate settings with high transmission risk and public impact under the Tuberculosis Prevention Act (e.g., healthcare facilities, schools) Persons deemed by the local government, under the Act, to require LTBI screening due to high TB risk (e.g., vagrants, people experiencing homelessness) (3) Individuals who understand the study procedures, voluntarily agree to participate, and sign a written informed consent form in advance.

Exclusion criteria

Exclusion criteria: (1) Aged =18 years. (2) History of prior tuberculosis treatment. (3) Any individual whom the principal investigator deems unsuitable for this clinical study for other reasons.

Design outcomes

Primary

MeasureTime frame
Adverse events occurring during latent tuberculosis infection treatment

Secondary

MeasureTime frame
Completion of latent tuberculosis infection (LTBI) treatment;Incident active tuberculosis

Countries

Korea, Republic of

Contacts

Public ContactJinsoo Min

The Catholic University of Korea, Seoul St. Mary's Hospital

minjinsoo@catholic.ac.kr+82-2-2258-6785

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 11, 2026