Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
190 participants
OBSERVATIONAL
2017-05-12
2028-12-31
Brief Summary
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2. The secondary objective is to determine biomarkers that discriminate children with TB infection and disease.
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Detailed Description
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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.
* performing NMR Analysis with biofluids in order to identify metabolomic signatures in patients with TB disease and TB infection
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TB exposure
Secreted cytokine assay
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).
Intracellular cytokine assay
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.
TB infection (latent TB)
Secreted cytokine assay
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).
Intracellular cytokine assay
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.
TB disease (active TB)
Secreted cytokine assay
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).
Intracellular cytokine assay
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.
Interventions
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Secreted cytokine assay
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).
Intracellular cytokine assay
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
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Inclusion Criteria
Exclusion Criteria
17 Years
ALL
No
Sponsors
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Ospedale Regionale Bellinzona e Valli
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
University of Lausanne Hospitals
OTHER
University Hospital, Geneva
OTHER
Luzerner Kantonsspital
OTHER
Cantonal Hospital of St. Gallen
OTHER
University Children's Hospital, Zurich
OTHER
Kantonsspital Aarau
OTHER
University Children's Hospital Basel
OTHER
Responsible Party
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Dr. Nicole Ritz, MD/PhD
PI
Principal Investigators
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Nicole Ritz, Prof Dr med
Role: PRINCIPAL_INVESTIGATOR
UKBB
Locations
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Kantonspital Aarau
Aarau, , Switzerland
Nina Vaezipour
Basel, , Switzerland
Ospedale Regionale di Bellinzona
Bellinzona, , Switzerland
Inselspital Bern
Bern, , Switzerland
Hôpital des enfants - HUG
Geneva, , Switzerland
Kinserspital Luzern
Lucerne, , Switzerland
Kinderspital St Gallen
Sankt Gallen, , Switzerland
Kinderklinik Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CITRUS
Identifier Type: -
Identifier Source: org_study_id
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