Diagnosis of Tuberculosis in Swiss Children (CITRUS)

University Children's Hospital Basel

Status

Enrolling

Conditions

Tuberculosis

Mycobacterium Tuberculosis

Treatments

Diagnostic Test: Intracellular cytokine assay

Diagnostic Test: Secreted cytokine assay

Study type

Observational

Funder types

Other

Identifiers

CITRUS

Details and patient eligibility

About

The primary objective is to improve the sensitivity of novel immunodiagnostic tests for detection of TB disease in children.
The secondary objective is to determine biomarkers that discriminate children with TB infection and disease.

Full description

This will be done by measuring a variety of parameters in the blood samples and compare them with the current diagnostic gold standard for TB or for culture/NAAT non-confirmed TB cases a consensus case definition is used.

Currently available immunodiagnostic tests (IGRA/TST) will be compared to novel immunodiagnostic tests which will include:
- several novel, additional M. tuberculosis-specific Antigens
- cytokines that are highly expressed
Since there is no diagnostic gold standard for TB infection we will rely on a clinical composite reference standard for diagnosing TB infection. Biomarkers will be determined by:
- including M. tuberculosis-specific antigens that are specifically expressed in either TB infection or disease,
- measuring phenotypes and cytokine production of M. tuberculosis-specific cells.
- performing NMR Analysis with biofluids in order to identify metabolomic signatures in patients with TB disease and TB infection

Enrollment

190 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

all children / adolescents < 18 years of age undergoing evaluation for TB exposure, infection or disease.

Exclusion criteria

children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously.