Performance of IGRAs for TB Infection Diagnosis in Elderly

Study Overview
=================
Brief Summary
-----------------
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context. TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.

Detailed Description
-----------------
In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis. Principal outcome: - 3 tests performance for active TB diagnosis in patients older than 75 years-old Secondary outcomes : concordance between IGRAs. non-concordant results analysis concordance of IGRAs results with time of TB-infection biobank Methodology :Diagnostic test performance study

Official Title
-----------------
Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)

Conditions
-----------------
Ageing, Tuberculosis

Intervention / Treatment
-----------------
* Other: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 75 years Consent signed hospitalized patient with start treatment of Tuberculosis disease French social right Exclusion Criteria: Tuberculosis disease treatment since 7 days No 3 months follow-up possible Immunosuppression

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active TB-infected patients<br>TB-infected patients with bacteriological and histological evidences | Other: Blood samples<br>* 4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml) 1 blood dry tube (5ml)<br>|
| Non active TB-infected patients (already met TB)<br>some of elders have already met M tuberculosis before active antibiotherapy exists | Other: Blood samples<br>* 4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml) 1 blood dry tube (5ml)<br>|
| Non active TB-infected patients (other diagnosis)<br>same symptoms than two others groups but an other diagnosis | Other: Blood samples<br>* 4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml) 1 blood dry tube (5ml)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive, indeterminate, negative tests in each group |  | month27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test results in clinical LTBI patients |  | month 27 | 
| Correlation with TB-infection date | Test results (positive/negative) according to LTBI date | month 27 | 
| Blood samples collection in order to test new hypothesis in patients with non-concordant results |  | month 27 | 
| Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®) |  | month 27 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ageing, Tuberculosis, Interferon gamma releasing tests