Diagnosis of Tuberculosis in Swiss Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorUniversity Children's Hospital Basel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all children / adolescents < 18 years of age undergoing evaluation for TB exposure, infection or disease.
Disqualifiers
children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Secreted cytokine assay
Diagnostic testBlood 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).
Intracellular cytokine assay
Diagnostic testBlood 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.
Treatment groups
190 Participants
are divided into 3 treatment groupsGroup A: TB exposure2 interventions
Group B: TB infection (latent TB)2 interventions
Group C: TB disease (active TB)2 interventions
Trial outcomes
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.
Time frame
27 monthsSecondary outcomes
1
Indicative markers identification for TB infection and disease distinction
A minimum sample size of 84 patients with TB infection is needed (with a precision given by a 95 % confidence interval with a width of 30 %). Among patients with TB infection or TB disease, a novel test is used to discriminate between these patient groups. It is estimated that the sensitivity of this test with regard to the identification of patients with TB infection (secondary outcome) is approximately 60 %.
Time frame
27 monthsSponsors and contacts
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University Children's Hospital Basel
Lead sponsor
Ospedale Regionale Bellinzona e Valli
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
University of Lausanne Hospitals
Collaborator
University Hospital, Geneva
Collaborator
Luzerner Kantonsspital
Collaborator
Cantonal Hospital of St. Gallen
Collaborator
University Children's Hospital, Zurich
Collaborator
Kantonsspital Aarau
Collaborator
Source ClinicalTrials.gov