NCT03044509UnknownNot Applicable
Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.
University Children's Hospital Basel8 sites in 1 country190 target enrollmentStarted: May 12, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 190
- Locations
- 8
- Primary Endpoint
- Improvement of immunodiagnostic tests for TB in children.
Study Overview
Brief Summary
- 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Improvement of immunodiagnostic tests for TB in children.
Time Frame: 27 months
Based on current evidence it is estimated that the sensitivity of the immunodiagnostic tests with regard to the identification of patients with TB infection or disease versus no TB is approximately 80 %. By applying a sample size approximation a minimum sample size of 126 patients with TB infection or disease (with a precision given by a 95 % confidence interval with a width of 20 %) will be needed to statistically show a significant result.
Secondary Outcomes
- Indicative markers identification for TB infection and disease distinction(27 months)
Investigators
Dr. Nicole Ritz, MD/PhD
PI
University Children's Hospital Basel
Study Sites (8)
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