Diagnostic marker to identify tuberculosis in close contact

Assessing the Diagnostic Potential of CD38+ IFN-gamma+ CD4+ T Cells Assay in diagnosing Subclinical, and Active Tuberculosis in Close Contacts of Smear-Positive Pulmonary Tuberculosis Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20240919001

Enrollment

100

Registered

2024-09-19

Start date

2024-12-02

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Incidence of subclinical, and active tuberculosis in close contact of smear-positive pulmonary tuberculosis Subclinical TB, Active TB, Closed contact, CD38+IFN-gamma+CD4+ T-cells

Interventions

People who live in the same household with a smear positive pulmonary tuberculosis patient, spending at least 120 hours per month together or at least 8 hours per day for more than 15 days. This also

Diagnostic

Close contact to smear positive TB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Individuals aged 18 years and older 2. Household/close contacts of patients diagnosed with pulmonary tuberculosis through smear-positive sputum results

Exclusion criteria

Exclusion criteria: 1. History of old pulmonary tuberculosis 2. Pregnancy 3. Autoimmune disease 4. Early-stage cancer or cancer under treatment or untreated within the past 2 years 5. Bone marrow or solid organ transplantation 6. Immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame
Incidence of subclinical, and active TB 3, 6, 9, 12 months Clinical and CD38+IFN-gamma+CD4+ T cells	—

Secondary

Measure	Time frame
CD38+IFN-gamma+CD4+ T cells cut-off for diagnosing subclinical TB 3, 6, 9, 12 months CD38+IFN-gamma+CD4+ T cells values and clinical diagnosis,Time to development of active TB 3, 6, 9, 12 months Clinical diagnosis,The relationship of other biomarkers, such as HLA-DR, CD27, and Ki-67, with the development of subclinical, and active TB 3, 6, 9, 12 months Biomarkers measurement and clinical diagnosis	—

Measure

Time frame

CD38+IFN-gamma+CD4+ T cells cut-off for diagnosing subclinical TB 3, 6, 9, 12 months CD38+IFN-gamma+CD4+ T cells values and clinical diagnosis,Time to development of active TB 3, 6, 9, 12 months Clinical diagnosis,The relationship of other biomarkers, such as HLA-DR, CD27, and Ki-67, with the development of subclinical, and active TB 3, 6, 9, 12 months Biomarkers measurement and clinical diagnosis

—

Countries

Thailand

Contacts

Public ContactMethee Chayakulkeeree

Faculty of Medicine Siriraj Hospital

methee.cha@mahidol.ac.th0850632416

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026