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Status unknownNCT04673227Updated Dec 17, 2020

Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)

An observational study in LTBI, BCG Vaccination Reaction and TB, sponsored by Thomayer University Hospital. Status unknown at 2 sites in Czechia. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Thomayer University Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
4 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • LTBI
  • BCG Vaccination Reaction
  • TB
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 120 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Thomayer University Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 70 Years
Sexes eligible
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

Eligibility criteria

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

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Exclusion Criteria:

  • HIV positive patients
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testBlood draw

    Blood draw and the analysis of blood in laboratory

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What researchers measure

Primary outcomes

  1. Peer-review publication of results of our study

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

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Study locations

2 of 2 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04673227
Lead sponsor
Thomayer University Hospital
Collaborators
Charles University, Czech Republic
Responsible party
Karolína Doležalová, M.D. (M.D., Thomayer University Hospital) — Principal investigator
First posted
Dec 17, 2020
Start date
Jan 2, 2020
Primary completion
May 26, 2020
Completion
Dec 26, 2022 (estimated)
Last update
Dec 17, 2020

Study contacts

Petra Hadlová, MGR
Contact
Petra.hadlova@natur.cuni.cz
+724077200
Karolína Doležalová, MD
Contact
karolina.dolezalova@ftn.cz
+420777246841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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