Clinical trial NCT01895582: Performance of IGRAs for TB Infection Diagnosis in Elderly
Official title: Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ageing
Tuberculosis
Keywords: Ageing
Tuberculosis
Interferon gamma releasing tests
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 160
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected tuberculosis disease

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

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

Primary outcomes:
measure: Number of positive, indeterminate, negative tests in each group
timeFrame: month27
Secondary outcomes:
measure: Test results in clinical LTBI patients
timeFrame: month 27
measure: Correlation with TB-infection date
timeFrame: month 27
measure: Blood samples collection in order to test new hypothesis in patients with non-concordant results
timeFrame: month 27
measure: Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)
timeFrame: month 27
Other outcomes:
Locations:
city: Bondy
country: France
facility: Service de médecine interne
city: Paris
country: France
facility: Servive de Médecine Interne (Pr S. Herson)
city: Strasbourg
country: France
facility: Service de Médecine Interne, Diabete et Maladies Métaboliques
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guislaine CARCELAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: