Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)
1 other identifier
observational
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2020
CompletedFirst Submitted
Initial submission to the registry
December 12, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2022
CompletedDecember 17, 2020
December 1, 2020
5 months
December 12, 2020
December 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Peer-review publication of results of our study
2 years
Secondary Outcomes (1)
Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST)
2 years
Study Arms (3)
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
Active TB group
Active TB group with positive microbial culture and pathological chest radiography or chest CT 20 children and adolescents 20 adults
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
Interventions
Blood draw and the analysis of blood in laboratory
Eligibility Criteria
Study of the broad spectrum of population with the history of having an active TB infection or close contact with bacteriologically approved pulmonary TB
You may not qualify if:
- HIV positive patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomayer University Hospitallead
- Charles University, Czech Republiccollaborator
Study Sites (2)
Faculty of Science
Prague, 12800, Czechia
Thomayer Hospital
Prague, 14059, Czechia
Biospecimen
30 ml of blood
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
December 12, 2020
First Posted
December 17, 2020
Study Start
January 2, 2020
Primary Completion
May 26, 2020
Study Completion
December 26, 2022
Last Updated
December 17, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share