NCT03044509

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 190 (estimated)
• Sponsor: University Children's Hospital Basel · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. 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 2. 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

Conditions

• Tuberculosis
• Mycobacterium Tuberculosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-12
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2017-02-07
• Last updated: 2024-09-19

Locations

8 sites across 1 country: Switzerland