Improving tuberculosis diagnosis 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.
This study is testing new blood tests to see if they can better diagnose tuberculosis in children compared to current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | University Children's Hospital Basel Academic / other |
| Locations | 8 sites (Aarau and 7 other locations) |
| Trial ID | NCT03044509 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the sensitivity of novel immunodiagnostic tests for detecting tuberculosis (TB) in children. It involves measuring various parameters in blood samples and comparing them with existing diagnostic standards for TB. The study will evaluate several new M. tuberculosis-specific antigens and cytokines, as well as perform NMR analysis to identify metabolomic signatures associated with TB infection and disease. The goal is to establish biomarkers that can effectively differentiate between TB infection and disease in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents under 18 years old who are being evaluated for TB exposure, infection, or disease.
Not a fit: Patients who have already started anti-mycobacterial treatment or have been previously treated for TB will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnosis of tuberculosis in children, improving treatment outcomes.
How similar studies have performed: Other studies have shown promise in improving TB diagnostics using novel immunodiagnostic approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarau and 7 other locations
- Kantonspital Aarau — Aarau, Switzerland (Recruiting)
- Nina Vaezipour — Basel, Switzerland (Recruiting)
- Ospedale Regionale di Bellinzona — Bellinzona, Switzerland (Recruiting)
- Inselspital Bern — Bern, Switzerland (Recruiting)
- Hôpital des enfants - HUG — Geneva, Switzerland (Recruiting)
- Kinserspital Luzern — Lucerne, Switzerland (Recruiting)
- Kinderspital St Gallen — Sankt Gallen, Switzerland (Recruiting)
- Kinderklinik Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nicole Ritz, Prof Dr med — Ukbb
- Study coordinator: Nina Vaezipour, Dr med
- Email: nina.vaezipour@ukbb.ch
- Phone: +41617042947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.