Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

• Conditions: BCG Vaccination Reaction; LTBI; TB
• Interventions: Diagnostic Test: Blood draw

• Registration Number: NCT04673227
• Lead Sponsor: Thomayer University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-02
• Primary Completion: 2020-05-26
• Status Verified: 2020-12
• Study First Submitted: 2020-12-12
• Study First Submitted QC: 2020-12-12
• Last Update Submitted: 2020-12-12
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Study Completion: 2022-12-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• HIV positive patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Contact with active TB/ negative	Blood draw	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
Contact with active TB/ LTBI	Blood draw	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
Active TB group	Blood draw	Active TB group with positive microbial culture and pathological chest radiography or chest CT 20 children and adolescents 20 adults

Primary Outcome Measures

Name	Time	Method
Peer-review publication of results of our study	2 years

Secondary Outcome Measures

Name	Time	Method
Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST)	2 years

Trial Locations

Locations (2)

Faculty of Science; 🇨🇿 Prague, Czechia

Thomayer Hospital; 🇨🇿 Prague, Czechia