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| Name | Class |
|---|---|
| Ospedale Regionale Bellinzona e Valli | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University of Lausanne Hospitals | OTHER |
| University Hospital, Geneva |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TB exposure |
| ||
| TB infection (latent TB) |
| ||
| TB disease (active TB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secreted cytokine assay | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 %. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Vaezipour, Dr med | Contact | +41617042947 | nina.vaezipour@ukbb.ch | |
| Nicole Ritz, Prof Dr med PhD | Contact | +41617042947 | nicole.ritz@unibas.ch |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Ritz, Prof Dr med | UKBB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonspital Aarau | Recruiting | Aarau | 5001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38730343 | Derived | 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. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| OTHER |
| Luzerner Kantonsspital | OTHER |
| Cantonal Hospital of St. Gallen | OTHER |
| University Children's Hospital, Zurich | OTHER |
| Kantonsspital Aarau | OTHER |
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For each child a total blood volume of 7.5 ml will be required for this study.
|
| Intracellular cytokine assay | Diagnostic Test | 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. |
|
| 27 months |
| Nina Vaezipour | Recruiting | Basel | 4056 | Switzerland |
|
| Ospedale Regionale di Bellinzona | Recruiting | Bellinzona | 6500 | Switzerland |
|
| Inselspital Bern | Recruiting | Bern | 3010 | Switzerland |
|
| Hôpital des enfants - HUG | Recruiting | Geneva | 1205 | Switzerland |
|
| Kinserspital Luzern | Recruiting | Lucerne | 6016 | Switzerland |
|
| Kinderspital St Gallen | Recruiting | Sankt Gallen | 9006 | Switzerland |
|
| Kinderklinik Zürich | Recruiting | Zurich | 8032 | Switzerland |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |