Diagnosis of Tuberculosis in Swiss Children

Summary

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.

Conditions

• Tuberculosis
• Mycobacterium Tuberculosis

Interventions

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.

Sponsors & Collaborators

• Ospedale Regionale Bellinzona e Valli

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Luzerner Kantonsspital

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• University Children's Hospital, Zurich

  collaborator OTHER

• Kantonsspital Aarau

  collaborator OTHER

• University Children's Hospital Basel

  lead OTHER

Principal Investigators

• Nicole Ritz, Prof Dr med · UKBB

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-12

Primary Completion

2026-12-31

Completion

2028-12-31

Countries

• Switzerland

Study Locations