Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: BCG Vaccination Reaction; LTBI; TB
• Intervention / Treatment: Diagnostic test: Blood draw

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Petra Hadlová, MGR; Phone Number: +724077200; Email: Petra.hadlova@natur.cuni.cz
• Study Contact Backup: Name: Karolína Doležalová, MD; Phone Number: +420777246841; Email: karolina.dolezalova@ftn.cz

Study Locations

• Czechia
  • Prague, Czechia, 12800
    • Recruiting
    • Faculty of Science
    • Contact: Petra Hadlová, Mgr.; Phone Number: +420724077200; Email: Petra.hadlova@natur.cuni.cz
    • Contact: Karel Drbal, Doc.; Email: Karel.drbal@natur.cuni.cz
  • Prague, Czechia, 14059
    • Recruiting
    • Thomayer Hospital
    • Contact: Karolína Doležalová, MD; Phone Number: +420261082337; Email: karolina.dolezalova@ftn.cz
    • Contact: Martina Vašáková, Prof; Phone Number: +261082372; Email: Martina.vasakova@ftn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study of the broad spectrum of population with the history of having an active TB infection or close contact with bacteriologically approved pulmonary TB

Description

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

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Exclusion Criteria:

• HIV positive patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Contact with active TB/ LTBI; 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	Diagnostic test: Blood draw; Blood draw and the analysis of blood in laboratory
Active TB group; Active TB group with positive microbial culture and pathological chest radiography or chest CT 20 children and adolescents 20 adults	Diagnostic test: Blood draw; Blood draw and the analysis of blood in laboratory
Contact with active TB/ negative; 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	Diagnostic test: Blood draw; Blood draw and the analysis of blood in laboratory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peer-review publication of results of our study	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomayer University Hospital
• Collaborators: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): May 26, 2020
• Study Completion (Anticipated): December 26, 2022

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: ThomayerH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No