Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

Thomayer University Hospital

Status: Unknown

Conditions: TB; BCG Vaccination Reaction; LTBI

Treatments: Diagnostic Test: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT04673227

ThomayerH

Details and patient eligibility

About

TB-reactive immune cells will be tested in a multiparametric flow cytometry to distinguish an immune response for antigens of Mycobacterium spp. in TB disease/latent infection or a reaction after BCG vaccine.

Full description

The goal of this project is the verification of current cytometric panel of detection antibodies in a wider panel of stimulative immunodominant antigens for CD4+ and CD8+ T cells in combination with adjuvants 2 in a in vitro activating test.

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: active TB, contact with TB infection in previous 3 months before the study

Exclusion Criteria:

• HIV positive patients

Trial design

120 participants in 3 patient groups

Contact with active TB/ LTBI

Description:

After a close contact with bacteriologically confirmed TB suspicion for LTBI with an evidence of previous BCG vaccination status TB confirmed with TST (TST ≥ 5 mm or BCG unvaccinated or TST ≥ 15 mm for BCG vaccinated) 20 children and adolescents 20 adults

Treatment:

Diagnostic Test: Blood draw

Active TB group

Description:

Active TB group with positive microbial culture and pathological chest radiography or chest CT 20 children and adolescents 20 adults

Treatment:

Diagnostic Test: Blood draw

Contact with active TB/ negative

Description:

After a close contact with bacteriologically confirmed TB no evidence of TB in TST or IGRA test for 3 months 20 children and adolescents 20 adults

Treatment:

Diagnostic Test: Blood draw