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NCT04673227 Clinical Trial

Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

TB Clinical Trial

Official title:
Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI) and the Influence of Previous BCG Vaccination - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04673227
Other study ID # ThomayerH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2020
Est. completion date December 26, 2022

Study information
Verified date December 2020
Source Thomayer Hospital
Contact Petra Hadlová, MGR
Phone +724077200
Email Petra.hadlova@natur.cuni.cz
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 26, 2022
Est. primary completion date May 26, 2020
Accepts healthy volunteers
Gender All
Age group 4 Years to 70 Years
Eligibility Inclusion Criteria: active TB, contact with TB infection in previous 3 months before the study - Exclusion Criteria: - HIV positive patients

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood draw
Blood draw and the analysis of blood in laboratory

Locations
Country Name City State
Czechia Faculty of Science Prague
Czechia Thomayer Hospital Prague

Sponsors (2)
Lead Sponsor Collaborator
Thomayer Hospital Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peer-review publication of results of our study 2 years
Secondary Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST) 2 years
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