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Evaluation of new and emerging diagnostics for childhood Tuberculosis in high burden countries

Research Project
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01.02.2010
 - 31.01.2013

Diagnosis and control of paediatric tuberculosis (TB) is often a low priority in tuberculosis-endemic regions, as children often develop sputum smear-negative disease and seldom contribute to transmission of TB. However, infants and children carry a large (15-25%) and increasing proportion of the overall burden of disease. Furthermore, young and HIV infected children have an increased risk of severe, rapidly progressive forms of tuberculosis, such as disseminated disease and meningitis. Establishing an accurate diagnosis particularly in immunocompromised children remains a challenge. The currently existing TB diagnostics for children carry a poor sensitivity and specificity. Suitable specimens, which are needed to confirm the diagnosis traditionally through positive acid-fast stains or positive cultures, are difficult to obtain from children. HIV and tuberculosis share many clinical features and with the existing approaches and technologies it is often impossible to exclude tuberculosis in HIV-infected children. Thus, more effective, rapid and affordable diagnostic tools are urgently needed for both treatment and clinical research in childhood TB. TB CHILD will undertake evidence-based clinical evaluation studies on new and improved TB diagnostics in order to find sensitive, fast and affordable tools. The clinical evaluation trials focus on childhood tuberculosis. However, newly developed diagnostic prototypes will be first investigated in adult TB suspects aiming to apply those - if promising - also in children. The studies of the TB CHILD project will comprehensively address this target by evaluating a large spectrum of novel diagnostic devices from point-of-care tools to tests suitable for higher level laboratories. The ultimate goal is to improve the means of diagnosing TB in children and to develop a concept for interventions that can advance management of childhood TB at different levels of health care. The overall objectives are the development of sustainable, collaborative research capacity for the diagnosis of childhood TB and the conduct of clinical trials on new or improved diagnostics for paediatric tuberculosis. The objectives will be reached through the following studies: A 'Proof of Principle' study in adult smear-positive TB cases (n= 180) and healthy controls (n=225) on new emerging diagnostic approaches will be performed and methodologies refined for later application in children. Investigations in adults are scientifically and ethically mandatory before an assessment in children will be performed. A systematic clinical evaluation of novel diagnostic methodologies in consecutively recruited child TB suspects will comprehensively assess the ability of new tests/approaches to reliably diagnose TB in children (n=600). Diagnostic accuracy, operational feasibility and appropriateness of the candidate tests/approaches for routine health care service implementation will evaluated. A specimen bank will be established at each site to provide a resource of well-characterized clinical reference materials from children and adults for further research on new TB diagnostics and TB drug resistance.

Members (5)

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Hans-Peter Beck

Principal Investigator
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Klaus Reither

Principal Investigator
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Fred Lwilla

Principal Investigator
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Claudia Daubenberger

Co-Investigator
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Levan Jugheli

Co-Investigator