Enhancement of the sensitivity of the Quantiferon test for patients with an inflammatory disease who are screened for presence of latent tuberculosis infection.
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In vitro production of interferon gamma (alternatively IP-10 could be used) in
a whole-blood test with specific TB antigens, in which test conditions will be
varied in order to enhance the sensitivity
Secondary outcome
Not applicable.
Background summary
Nowadays more patients with an inflammatory disease, such as RA or Crohn's
disease, are treated with biologicals of which TNF antagonists are the most
used. However, TNF antagonists significantly increase the risk of reactivation
of latent tuberculosis. That is why all patients are screened for presence of
latent tuberculosis infection. This screening is limited due to the low
specificity of the tuberculin skin test, while the highly specific Quantiferon
TB Gold test has a suboptimal sensitivity for detecting latent tuberculosis
infection in the remote past or in persons with active inflammatory disease or
using immunosuppression.
Hypothesis: it is possible to enhance the sensitivity of the in vitro
whole-blood test for detecting latent tuberculosis infection by varying test
conditions or addition of immune modulating agents.
Study objective
Enhancement of the sensitivity of the Quantiferon test for patients with an
inflammatory disease who are screened for presence of latent tuberculosis
infection.
Study design
Research will be done in the form of a pilot study. It is unknown which of the
in vitro variations could enhance the sensitivity of the Quantiferon test. That
is why venous blood sampling from small numers patients and controls will be
done for each experiment. This allows judgement per experiment of which
variables are favourable and therefore worthy of further investigation in more
patients.
In case the exploratory part of the study reveals favourable results, the most
promising test conditions will be tested in a different group of patients
(N=30) in order to validate these results.
Study burden and risks
The risk of two performances of venapunction is minimal.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients with an inflammatory disease who are or have been previously screened for latent tuberculosis infection (with or without current treatment with a TNF antagonist)
negative controls: healthy uninfected individuals
positive controls: known latent TB infection or previously treated TB patients
Exclusion criteria
none
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 | NL40310.058.12 |