LTBINCT04673227
Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)
An observational study of LTBI and BCG Vaccination Reaction, run by Thomayer University Hospital at 2 sites in Czechia.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- LTBI, BCG Vaccination Reaction, TB
- What is being tested?
- Blood draw
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 2 sitesCzechia
- Study dates
- 2 Jan 2020to 26 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 70 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- HIV positive patients
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Faculty of Science
Prague, 12800
Petra Hadlová, Mgr., +420724077200, Petra.hadlova@natur.cuni.cz
Karel Drbal, Doc., Karel.drbal@natur.cuni.cz
- Recruiting
Thomayer Hospital
Prague, 14059
Karolína Doležalová, MD, +420261082337, karolina.dolezalova@ftn.cz
Martina Vašáková, Prof, +261082372, Martina.vasakova@ftn.cz
About this study
Official title: 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.
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.
- Conditions
- LTBI, BCG Vaccination Reaction, TB
- Being tested
- Blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Blood draw and the analysis of blood in laboratory
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer-review publication of results of our study
Measured: 2 years
Secondary outcomes (1)
Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Jan 2020
- Primary completion26 May 2020
- Study completion26 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LTBIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Thomayer University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Principal investigator, Karolína Doležalová, M.D., Thomayer University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673227
- Sponsor's protocol ID
- ThomayerH
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI) and the Influence of Previous BCG Vaccination - Pilot Study
- ClinicalTrials.gov ID
- NCT04673227
- Acronym / sponsor ID
- ThomayerH
- Conditions
- LTBI, BCG Vaccination Reaction, TB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Thomayer University HospitalUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 Dec 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contact with active TB/ LTBI | – | Diagnostic Test: Blood drawAfter 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 | – | Diagnostic Test: Blood drawActive TB group with positive microbial culture and pathological chest radiography or chest CT 20 children and adolescents 20 adults |
| Contact with active TB/ negative | – | Diagnostic Test: Blood drawAfter 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 |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- HIV positive patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw and the analysis of blood in laboratory | Diagnostic test | Active TB group, Contact with active TB/ LTBI, Contact with active TB/ negative |
Primary outcome
Peer-review publication of results of our study
Time frame: 2 years
1 secondary outcome
Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for LTBI
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingPhase 2/3
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Tuberculosis, Latent
RecruitingPhase 2
BPaLMZ for TB Meningitis
Tuberculous Meningitis, HIV
Recruiting
Screening With Portable X-rays for Rapid Recognition of TB
Tuberculosis (TB), Tuberculosis Infection, Latent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LTBI and BCG Vaccination Reaction, run by Thomayer University Hospital at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Hadlová, MGR (+724077200, Petra.hadlova@natur.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peer-review publication of results of our study (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.