Performance of IGRAs for TB Infection Diagnosis in Elderly

NCT01895582 | Terminated

• 2 other identifiers: P1101312012-A00326-37
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Ageing; Tuberculosis

Keywords

Ageing; Tuberculosis; Interferon gamma releasing tests

Outcome Measures

Primary Outcomes (1)

• Number of positive, indeterminate, negative tests in each group

  month27

Secondary Outcomes (4)

• Test results in clinical LTBI patients

  month 27

• Correlation with TB-infection date

  month 27

• Blood samples collection in order to test new hypothesis in patients with non-concordant results

  month 27

• Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)

  month 27

Study Arms (3)

Active TB-infected patients

TB-infected patients with bacteriological and histological evidences

Other: Blood samples

Non active TB-infected patients (already met TB)

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

Other: Blood samples

Non active TB-infected patients (other diagnosis)

same symptoms than two others groups but an other diagnosis

Other: Blood samples

Interventions

Blood samples OTHER

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

Active TB-infected patients; Non active TB-infected patients (already met TB); Non active TB-infected patients (other diagnosis)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected tuberculosis disease

You may qualify if:

• Age \> 75 years
• Consent signed
• hospitalized patient with start treatment of Tuberculosis disease
• French social right

You may not qualify if:

• Tuberculosis disease treatment since 7 days
• No 3 months follow-up possible
• Immunosuppression

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Service de médecine interne

Bondy, 93143, France

Location

Servive de Médecine Interne (Pr S. Herson)

Paris, 75013, France

Location

Service de Médecine Interne, Diabete et Maladies Métaboliques

Strasbourg, 67000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Tuberculosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Guislaine CARCELAIN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 10, 2013
• Study Start: July 17, 2013
• Primary Completion: March 17, 2019
• Study Completion: March 17, 2019
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

FR (3)