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Performance of IGRAs for TB Infection Diagnosis in Elderly

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01895582
Acronym
IGRage
Enrollment
160
Registered
2013-07-10
Start date
2013-07-17
Completion date
2019-03-17
Last updated
2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ageing, Tuberculosis

Keywords

Ageing, Tuberculosis, Interferon gamma releasing tests

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

Interventions

OTHERBlood samples

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of positive, indeterminate, negative tests in each groupmonth27

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026