Tuberculosis Clinical Trial
Official title:
Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.
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.
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. ;
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