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NCT Number: NCT03044509

Diagnosis of Tuberculosis in Swiss Children

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Mycobacterium Tuberculosis

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonspital Aarau, Aarau, Switzerland

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About this study

  • 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:

  • several novel, additional M. tuberculosis-specific Antigens
  • cytokines that are highly expressed
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Improvement of immunodiagnostic tests for TB in children.

    Time frame: 27 months

    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.

Secondary outcomes

  1. Indicative markers identification for TB infection and disease distinction

    Time frame: 27 months

    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 %.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Ritz, Prof Dr med PhD

CONTACT

[email protected]

+41617042947

Nina Vaezipour, Dr med

CONTACT

[email protected]

+41617042947

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Collaborators

  • Cantonal Hospital of St. Gallen
  • Insel Gruppe AG, University Hospital Bern
  • Kantonsspital Aarau
  • Luzerner Kantonsspital
  • Ospedale Regionale Bellinzona e Valli
  • University Children's Hospital, Zurich
  • University Hospital, Geneva
  • University of Lausanne Hospitals

Registry information

Official study title

Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.

Acronym: CITRUS

Important dates

Study start
2017
Primary completion
2026
Study completion
2028
First posted
Feb 7, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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