Performance of IGRAs for TB Infection Diagnosis in Elderly

Tuberculosis Clinical Trial

— IGRage  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01895582
• Other study ID #: P110131
• Secondary ID: 2012-A00326-37
• Status: Terminated
• Start date: July 17, 2013
• Est. completion date: March 17, 2019

Study information

• Verified date: May 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: March 17, 2019
• Est. primary completion date: March 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ageing
• Tuberculosis

Intervention

Other:
• Blood samples
4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml) 1 blood dry tube (5ml)

Locations

Country	Name	City	State
France	Service de médecine interne	Bondy
France	Servive de Médecine Interne (Pr S. Herson)	Paris
France	Service de Médecine Interne, Diabete et Maladies Métaboliques	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of positive, indeterminate, negative tests in each group		month27
Secondary	Test results in clinical LTBI patients		month 27
Secondary	Correlation with TB-infection date	Test results (positive/negative) according to LTBI date	month 27
Secondary	Blood samples collection in order to test new hypothesis in patients with non-concordant results		month 27
Secondary	Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)		month 27