Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

NCT ID: NCT04673227

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-02

Study Completion Date

2022-12-26

Brief Summary

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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

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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.

Conditions

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LTBI BCG Vaccination Reaction TB

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Blood draw

Intervention Type DIAGNOSTIC_TEST

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

Blood draw

Intervention Type DIAGNOSTIC_TEST

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

Blood draw

Intervention Type DIAGNOSTIC_TEST

Blood draw and the analysis of blood in laboratory

Interventions

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Blood draw

Blood draw and the analysis of blood in laboratory

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* HIV positive patients
Minimum Eligible Age

4 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Thomayer University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karolína Doležalová, M.D.

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Science

Prague, , Czechia

Site Status RECRUITING

Thomayer Hospital

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Petra Hadlová, MGR

Role: CONTACT

Phone: +724077200

Email: [email protected]

Karolína Doležalová, MD

Role: CONTACT

Phone: +420777246841

Email: [email protected]

Facility Contacts

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Petra Hadlová, Mgr.

Role: primary

Karel Drbal, Doc.

Role: backup

Karolína Doležalová, MD

Role: primary

Martina Vašáková, Prof

Role: backup

Other Identifiers

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ThomayerH

Identifier Type: -

Identifier Source: org_study_id