Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

• Sponsor: Thomayer University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04673227
• Collaborator: Charles University, Czech Republic (Other)
• Enrollment: 120
• Locations: 2
• Anticipated Duration (Months): 35.8
• Patients Per Site: 60
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
LTBI; BCG Vaccination Reaction; TB	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI) and the Influence of Previous BCG Vaccination - Pilot Study
• Actual Study Start Date: Jan 2, 2020
• Actual Primary Completion Date: May 26, 2020
• Anticipated Study Completion Date: Dec 26, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Peer-review publication of results of our study [2 years]

Secondary Outcome Measures

1. Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST) [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 70 Years
• Sexes Eligible for Study: All

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

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Exclusion Criteria:

• HIV positive patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Science	Prague		Czechia	12800
2	Thomayer Hospital	Prague		Czechia	14059

Sponsors and Collaborators

• Thomayer University Hospital
• Charles University, Czech Republic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karolína Doležalová, M.D., M.D., Thomayer University Hospital
• ClinicalTrials.gov Identifier: NCT04673227
• Other Study ID Numbers: ThomayerH
• First Posted: Dec 17, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tuberculosis; Latent Tuberculosis

Study Results

No Results Posted as of Dec 17, 2020