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RECRUITINGOBSERVATIONAL

Diagnosis of Tuberculosis in Swiss Children

Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

1. The primary objective is to improve the sensitivity of novel immunodiagnostic tests for detection of TB disease in children. 2. The secondary objective is to determine biomarkers that discriminate children with TB infection and disease.

Who May Be Eligible (Plain English)

Who May Qualify: - all children / adolescents \< 18 years of age undergoing evaluation for TB exposure, infection or disease. Who Should NOT Join This Trial: - children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

Secreted cytokine assay

Blood collected in a sodium-heparin tube will be used for the assay using novel TB-specific antigens. After incubation the supernatant will be harvested and cryopreserved at -80 °C for further testing of cytokines. Cytokines will be measured using a bead-based multiplex assay reader (MAGPIX, Luminex Crop., Austin, USA).

DIAGNOSTIC_TEST

Intracellular cytokine assay

Blood will be stimulated with recombinant MTB-specific antigens, ESAT-6, CFP-10, positive control or left unstimulated. Following an initial duration of stimulation, Brefeldin-A will be added and the blood incubated for a further 5 hours. White cells will be fixed and cryopreserved at - 80°. Batched analysis within 6 months of cryopreservation will be done using multi-colour flow cytometry.

Locations (8)

Kantonspital Aarau
Aarau, Switzerland
Nina Vaezipour
Basel, Switzerland
Ospedale Regionale di Bellinzona
Bellinzona, Switzerland
Inselspital Bern
Bern, Switzerland
Hôpital des enfants - HUG
Geneva, Switzerland
Kinserspital Luzern
Lucerne, Switzerland
Kinderspital St Gallen
Sankt Gallen, Switzerland
Kinderklinik Zürich
Zurich, Switzerland