Performance of IGRAs for TB Infection Diagnosis in Elderly

NCT ID: NCT01895582

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-17
• Study Completion Date: 2019-03-17

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

Conditions

Ageing; Tuberculosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Active TB-infected patients

TB-infected patients with bacteriological and histological evidences

Blood samples

Intervention Type: OTHER

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)

Non active TB-infected patients (already met TB)

some of elders have already met M tuberculosis before active antibiotherapy exists

Blood samples

Intervention Type: OTHER

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)

Non active TB-infected patients (other diagnosis)

same symptoms than two others groups but an other diagnosis

Blood samples

Intervention Type: OTHER

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)

Interventions

Blood samples

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)

Intervention Type: OTHER

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guislaine CARCELAIN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de médecine interne

Bondy, , France

Servive de Médecine Interne (Pr S. Herson)

Paris, , France

Service de Médecine Interne, Diabete et Maladies Métaboliques

Strasbourg, , France

Countries

France

Other Identifiers

2012-A00326-37

Identifier Type: OTHER

Identifier Source: secondary_id

P110131

Identifier Type: -

Identifier Source: org_study_id