Performance of IGRAs for TB Infection Diagnosis in Elderly

Terminated

• Conditions: Ageing; Tuberculosis
• Interventions: Other: Blood samples

• Registration Number: NCT01895582
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-10
• Study Start: 2013-07-17
• Primary Completion: 2019-03-17
• Study Completion: 2019-03-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non active TB-infected patients (other diagnosis)	Blood samples	same symptoms than two others groups but an other diagnosis
Active TB-infected patients	Blood samples	TB-infected patients with bacteriological and histological evidences
Non active TB-infected patients (already met TB)	Blood samples	some of elders have already met M tuberculosis before active antibiotherapy exists

Primary Outcome Measures

Name	Time	Method
Number of positive, indeterminate, negative tests in each group	month27

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Servive de Médecine Interne (Pr S. Herson); 🇫🇷 Paris, France

Service de médecine interne; 🇫🇷 Bondy, France

Service de Médecine Interne, Diabete et Maladies Métaboliques; 🇫🇷 Strasbourg, France