Diagnosis of Tuberculosis in Swiss Children
CITRUS
Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.
1 other identifier
observational
190
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2017
CompletedStudy Start
First participant enrolled
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
September 19, 2024
September 1, 2024
9.6 years
February 3, 2017
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of immunodiagnostic tests for TB in children.
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.
27 months
Secondary Outcomes (1)
Indicative markers identification for TB infection and disease distinction
27 months
Study Arms (3)
TB exposure
TB infection (latent TB)
TB disease (active TB)
Interventions
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).
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.
Eligibility Criteria
It will be a national multicentre study in Switzerland. Children will be recruited within SwissPedNet, the Swiss Research Network of Clinical Paediatric Hubs, which includes five University Children's Hospitals (Basel, Bern, Geneva, Lausanne and Zürich) and four cantonal A-clinics (Aarau, Bellinzona, Luzern and St. Gallen). Currently approximately 20-30 children with TB disease are notified in Switzerland each year. For TB infection in children there are no data available in Switzerland. However, data from the "Lungenliga Schweiz" show that in 2014, at least 232 children were examined for a TB contact investigation (correspondence with Jean-Pierre Zellweger and Jean-Marie Egger, Lungenliga Schweiz 13.08.2015). Of these 13 % (i.e. around 30 children) are categorized as TB infection per year.
You may qualify if:
- all children / adolescents \< 18 years of age undergoing evaluation for TB exposure, infection or disease.
You may not qualify if:
- children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Children's Hospital Basellead
- Ospedale Regionale Bellinzona e Vallicollaborator
- Insel Gruppe AG, University Hospital Berncollaborator
- University of Lausanne Hospitalscollaborator
- University Hospital, Genevacollaborator
- Luzerner Kantonsspitalcollaborator
- Cantonal Hospital of St. Gallencollaborator
- University Children's Hospital, Zurichcollaborator
- Kantonsspital Aaraucollaborator
Study Sites (8)
Kantonspital Aarau
Aarau, 5001, Switzerland
Nina Vaezipour
Basel, 4056, Switzerland
Ospedale Regionale di Bellinzona
Bellinzona, 6500, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Hôpital des enfants - HUG
Geneva, 1205, Switzerland
Kinserspital Luzern
Lucerne, 6016, Switzerland
Kinderspital St Gallen
Sankt Gallen, 9006, Switzerland
Kinderklinik Zürich
Zurich, 8032, Switzerland
Related Publications (1)
Neudecker D, Fritschi N, Sutter T, Lu LL, Lu P, Tebruegge M, Santiago-Garcia B, Ritz N. Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol. BMC Infect Dis. 2024 May 10;24(1):481. doi: 10.1186/s12879-024-09359-0.
PMID: 38730343DERIVED
Biospecimen
For each child a total blood volume of 7.5 ml will be required for this study.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Ritz, Prof Dr med
UKBB
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 7, 2017
Study Start
May 12, 2017
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share