Rapid and Accurate Diagnosis of Paediatric TB (RaPaed-AIDA-TB)

Summary

This study will serve as a platform to evaluate new diagnostics in children suspected to have TB, establish diagnostic performance (sensitivity and specificity) and calculate positive and negative predictive values in a real-life cohort.

Finally, this study will comprise the results of several tests in its database. This will allow simulation of diagnostic algorithms, that may be composed of screening (i.e. rule-out) tests together with confirmatory tests to maximize sensitivity and specificity.

Conditions

• Tuberculosis
• Diagnoses Disease

Interventions

DIAGNOSTIC_TEST

Sample collection

Specimen collection

Sponsors & Collaborators

• University of Cape Town Lung Institute

  collaborator OTHER

• Instituto Nacional de Saúde, Mozambique

  collaborator OTHER_GOV

• Kamuzu University of Health Sciences

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Research Center Borstel

  collaborator OTHER

• University of Stellenbosch

  collaborator OTHER

• Beckman Coulter, Inc.

  collaborator INDUSTRY

• Cepheid

  collaborator INDUSTRY

• Otsuka Novel Products GmbH

  collaborator INDUSTRY

• University of Melbourne

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  collaborator OTHER

• National Institute for Medical Research, Tanzania

  collaborator OTHER_GOV

• Christian Medical College, Vellore, India

  collaborator OTHER

• Michael Hoelscher

  lead OTHER

Principal Investigators

• Michael Hoelscher, Professor · University Hospital, LMU Munich

• Norbert Heinrich, MD · University Hospital, LMU Munich

Eligibility

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-21

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• India
• Malawi
• Mozambique
• South Africa
• Tanzania

Study Locations