Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

• Conditions: BCG Vaccination Reaction; LTBI; TB

• 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

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