Project: Rapid and accurate diagnosis of paediatric TB
| Acronym | RaPaed (Reference Number: RIA2016MC-1623) |
| Duration | 01/02/2018 - 31/07/2022 |
| Project Topic | Tuberculosis (TB) is a major cause of child morbidity and mortality in the world. There are an estimated one million new pediatric cases and at least 209.000 deaths per year. As childhood mortality on TB treatment is low at 1%, this highlights the fact that a large proportion of cases are never diagnosed and thereby never received appropriate treatment. The inability to correctly and timely diagnose paediatric TB is the main obstacle to control disease and prevent adverse outcomes, specifically among infants and young children, children with malnutrition, HIV-infection, and drug-resistant TB. Pediatric samples, which are difficult to obtain, have small volumes and low bacterial burden, leading to low sensitivity of currently applied diagnostic tests for TB, which are geared towards adults. The World Health Organization has clearly stated that new and improved diagnostics for children are a top priority. With RaPaed TB, we propose a project that is ideally suited to evaluate a range of novel diagnostics and sampling strategies in a population of symptomatic children with presumptive TB with a high likelihood of myobacteriological confirmation of disease. The key aspects of the project will be a multi-site collaboration of four geographically distinct sites in highly TB endemic settings allowing a large sample size, high proportion of bacteriologically confirmed cases, and making study findings generalizable. We include internationally recognized experts in child TB clinical research; FIND’s panel of diagnostic tests andexpertise in diagnostics development and evaluation as well in the WHO submission and review process of the gathered data; LMU with its track record of delivering high-quality studies in the TB field; two large industry partners dedicated to the development of robust point-of-care assays; and finally, early involvement of National TB Programmes in the studies which will not only add to local capacity development, but also enable rapid local approval and uptake. We are proposing to assess eight new diagnostic techniques suitable for children in this study. This includes a new stool protocol for Xpert Ultra®, TAM TB from the University of Munich/Beckman Coulter, a biomarker panel by the University of Stellenbosch, a host RNA test, and two novel urinary LAM tests (see test characteristic summary). We realistically think that this study will lead to WHO endorsement or recommendation of at least two or more new assays or sampling strategies; with FIND leading the WHO submission process which could therefore impact childhood TB policies globally. |
| Network | EDCTP2 |
| Call | Clinical trials and operational research studies to optimise the use of products for poverty-related diseases in mothers, newborns, children and/or adolescents |
Project partner
| Number | Name | Role | Country |
|---|---|---|---|
| 1 | Ludwig-Maximilians-Universitaet Muenchen | Coordinator | Germany |
| 4 | Forschungszentrum Borstel Leibniz-Zentrum für Medizin ud Biowissenschaften | Partner | Germany |
| 5 | Foundation for Innovative New Diagnostics | Partner | Switzerland |
| 6 | Instituto Nacional de Saúde | Partner | Mozambique |
| 8 | Karolinska Institutet | Partner | Sweden |
| 9 | National Institute for Medical Research - Tanzania | Partner | Tanzania |
| 11 | Stellenbosch University | Partner | South Africa |
| 12 | University of Cape Town Lung Institute (Pty) Ltd | Partner | South Africa |
| 14 | University of Malawi, College of Medicine | Partner | Malawi |
| 16 | University of Melbourne | Partner | Australia |