Primary Objectives: To explore whether QFT-plus is equipped to differentiate between active TB disease and latent TB infectionTo explore a possible correlation between QFT-plus response and time after TB-infection and/or diagnosis tuberculosis /…
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The differences in QFT-Plus assay results (positive or negative) and the level
of response between the different tubes and different groups
The differences in QFT-Plus assay response during treatment in subjects with
active tuberculosis
Secondary outcome
Other cytokines than interferon gamma enabling to distinguish active TB disease
from latent TB infection
Cell characteristics enabling to distinguish active TB disease from latent TB
infection
Background summary
Mycobacterium tuberculosis (MTB) still remains a major threat for human health.
Diagnosing tuberculosis (TB) is still a challenge and distinguishing active
from latent infection can be very difficult. Interferon-gamma release assays
(IGRAs) are diagnostic tools for latent tuberculosis infection (LTBI). Two
IGRAs are available in many countries: the QuantiFERON-TB Gold assay and the
T-SPOT.TB assay.
In 2015, QuantiFERON-TB Gold Plus (QFT-Plus), an updated version of the the
QuantiFERON-TB Gold assay, will be introduced by Qiagen. Based on the
components, especially the TB-specific CD8+ T cell immunology, this new test
possibly might differentiate between latent and active tuberculosis, and might
contribute in treatment monitoring. These questions are not studied yet.
Furthermore, except measuring interferon gamma production, this test (QFT-Plus)
enables to identify other potential cytokines to distinguish between active TB
disease and latent TB infection as well as analyzing functional characteristics
of the cells as a potential tool in distinguishing active from latent TB.
Study objective
Primary Objectives:
To explore whether QFT-plus is equipped to differentiate between active TB
disease and latent TB infection
To explore a possible correlation between QFT-plus response and time after
TB-infection and/or diagnosis tuberculosis / latent tuberculosis infection
To explore QFT-plus kinetics during treatment in patients with active
tuberculosis
Secondary Objectives:
To identify other, potential cytokines, enabling to distinguish active TB
disease from latent TB infection
To analyze (functional) cell characteristics enabling to distinguish active TB
disease from latent TB infection
Study design
Explorative proof of concept study
Study burden and risks
No risks and benefits are expected for participation. All volunteers are asked
for a single vena punction, except them treated for active tuberculosis at this
moment. They will asked for three more vena punctions during treatment. For all
persons, a standard questionnaire and study of medical file for baseline
characteristics are completed.
Bosboomstraat 1
Utrecht 3582 KE
NL
Bosboomstraat 1
Utrecht 3582 KE
NL
Listed location countries
Age
Inclusion criteria
Latent or active tuberculosis in history or at this moment
Exclusion criteria
Age < 18 years
Known HIV-infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53628.100.15 |