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World Tuberculosis Day 2021 – The clock is ticking: RaPaed-AIDA-TB project aims to tackle child mortality

Recruitment success lays foundation for new diagnostic tools and testing strategies to combat childhood tuberculosis

Photo: WHO - World TB Day 2021

24th of March is World Tuberculosis Day. Every year, more than one million children fall ill with tuberculosis (TB) globally, and about a quarter of them die from the potentially preventable and curable disease. According to the World Health Organization (WHO), tuberculosis is one of the ten most frequent causes of death among children under five years of age. The main obstacle remains the correct and timely identification of the disease, especially in resource-constrained settings. New tests are required, that would work with samples that can be easily obtained from children. Led by Dr. Norbert Heinrich at the Division of Infectious Diseases and Tropical Medicine of the LMU University Hospital Munich, an international consortium* of researchers is therefore carrying out the RaPaed-AIDA-TB Project (Rapid and Accurate Diagnosis of Paediatric TB - An AIDA (Assessment of Innovative Diagnostic and Algorithms for Early and Sensitive Detection of Acute TB)).

RaPaed is one of the largest cohorts and diagnostic studies evaluating a range of new diagnostics ever in childhood TB, is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), and the German Center for Infection Research (DZIF). The core of the project is a large diagnostic validation study, which is carried out together with local partners in five countries, including four sites in Africa (South Africa, Tanzania, Mozambique, Malawi), and one in India. Eight new diagnostic test candidates are evaluated on all children in the study, and their performance compared to the reference standard used in child diagnostic validation studies. In total, 10 diagnostics/diagnostic approaches being studied in RaPaed.

Successful recruitment in one of the largest studies in childhood TB

After the start of the study in 2018, the study team has now achieved a significant recruitment milestone: So far, over 820 children with suspected TB have been enrolled in RaPaed-AIDA-TB. The overall target is to recruit 1,000. Further study participants are now being recruited in collaboration with the Christian Medical College (CMC) in Vellore, India.

Dr. Robina Semphere, study physician at one of the other enrolling sites, the College of Medicine (CoM), University of Malawi, Blantyre, Malawi, explains: “The process of recruitment into the RaPaed study has indirectly contributed to the screening, diagnosis and management of pediatric tuberculosis in our tertiary health facility. Through the RaPaed study, a dedicated clinical team conducts daily TB screening, links those not recruited to appropriate care, identifies patients in need of an earlier follow up date through phone-call check-ups, and creates access to services, that would have otherwise been unavailable (such as tuberculin skin tests or the sputum induction procedure) or slow in turn-around time (such as the gene Xpert ultra). The holistic approach taken through this study demonstrates the impact that studies can have if they not only focus on the potential future patients that their results will benefit, but are intentional about positively contributing to the site they recruit from, the staff they work with, and the patients that are currently affected by the illness they study.”

The project brings together experienced academic medical study centers and a clinical trials unit at LMU, with academic test developers and major industry partners. Tests are established with promising platforms that will enable testing at point-of-care or in district hospital settings with acceptable referral timelines. RaPaed-AIDA-TB also supports the building of capacity to diagnose TB in children locally and includes further training of African researchers, in order to strengthen health structures and research globally.

Dr. Laura Olbrich, MD, one of the study coordinators at the LMU University Hospital Munich, stresses the need for further research: “TB in children is a neglected problem within a neglected disease. In contrast to the high number of children who die from tuberculosis, only little attention is paid to the global burden of childhood TB. RaPaed makes a relevant contribution to filling the gap regarding paediatric coverage in TB.”

RaPaed-team web

Photo/Copyright: RaPaed team


*The RaPaed project consortium:

Coordinator:
LMU University Hospital Munich

Clinical Study Centres:
National Institute for Medical Research (NIMR – MMRC), Mbeya, Tanzania
Instituto Nacional de Saúde (INS), Mozambique
University of Malawi College of Medicine (CoM), Blantyre, Malawi
University of Cape Town Lung Institute (UCTLI), Cape Town, South Africa
Christian Medical College (CMC), Vellore, India

Consortium & Partners:
LMU, Munich, Germany
Foundation for Innovative New Diagnostics (FIND), Switzerland
University of Melbourne, Australia
Stellenbosch University, South Africa
Karolinska Institute, Sweden
Research Center Borstel, Germany
NTP Tanzania, NTP Mozambique
MoH, Malawi
OVG, Oxford University, UK

Industry partners:
Beckman Coulter, Inc.
Cepheid

RaPaed-AIDA-TB is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP; RIA2016MC -1623) and the German Center for Infection Research (DZIF)

Detailed overview of the RaPaed consortium (cf. organogram)

Further information: https://www.rapaed.org


Press contact:
Dr. Laura Olbrich, MD
Clinician Scientist, Coordinating Scientist
LMU University Hospital Munich
Division of Infectious Diseases and Tropical Medicine
E-Mail: Olbrich@lrz.uni-muenchen.de
Phone: +49 (0)89 4400 59803