Tuberculosis Clinical Trial
Official title:
Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.
Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some
patients will develop tuberculosis and some will only be infected without symptoms, they
have Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent
this tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need
anti TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this
test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection
are now available.
The primary endpoint of this study is the evaluation of the theoric therapeutic impact of
the use of new tests for diagnosis of LTBI in patients before anti TBF therapy
Detailed description :
Principal outcome: Therapeutic impact of the use of new tests for diagnosis of LTBI in
patients before anti TBF therapy
Secondary outcomes :
- medico-economic impact of replacement of TST by QFTB-G and T-SPOT.TB tests in LTBI
screening in patients before anti TNF therapy.
- concordance of QFTB-G and T-SPOT.TB tests results with TST
- Concordance between QFTB-G and T-SPOT.TB tests and evaluation of indetermined tests.
- concordance of QFTB-G and T-SPOT.TB tests results with patient disease.
- concordance of QFTB-G and T-SPOT.TB tests results with TST in patients with LTBI
determinated by clinical or radiological observation
- Impact of geographical, disease and treatment in patients with LTBI determinated by
clinical or radiological observation
- Identify the original characteristic and maximal impact therapeutic of QFTB-G and
T-SPOT.TB test
Analysed criteria :
- therapeutic impact
- Patients percentage with different therapeutic outcome based on usual recommendations
medico-economic
- Medico-economic impact :impact of both tests as early and late cost - efficacy
Statistic :
- Primary criteria : Percentage of patients for whom therapeutic would have been changed
by QFTB-G and T-SPOT.TB tests results compared to usual diagnosis strategy.
- Secondary criteria : Concordance of QFTB-G and T-SPOT.TB tests with TST Concordance
between both QFTB-G and T-SPOT.TB tests .
400 patients Timing : inclusions : 1 years
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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