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Paediatric operational research

5 Jun 2018

The aims of this research area are to firstly evaluate and identify gaps in the current health systems providing care to children with TB, and secondly to pilot innovative solutions and measure the impact thereof through rigorous implementation science methodology. Current projects focusses on optimizing surveillance strategies, prevention and routine data for children with TB, including HIV co-infected children.

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Operational Research Assistance Project (ORAP)

5 Jun 2018

The overall aim of ORAP is to undertake operational research as an integral component of health programmes in South Africa to contribute to improved quality and performance of the health system.

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Intra-thoracic tuberculosis in children: moving towards better diagnosis and improved lung health (UMOYA “breathe”)

5 Jun 2018

The study will continue to evaluate improved diagnostic strategies for paediatric TB, including novel laboratory techniques for both molecular and culture-based diagnosis on respiratory and stool specimens.

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Lung health, diagnostic and biomarker studies

5 Jun 2018

The diagnostic platform nested in the DTTC paediatric programme focuses on improving the diagnosis of TB in children.

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Vaccine Project Management (VPM)

5 Jun 2018

This trial evaluated the safety and immunogenicity of a novel recombinant BCG vaccine in HIV-exposed and unexposed infants. Completed in 2016, data analysis ongoing.

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Bedaquiline CRUSH Study

5 Jun 2018

To assess the bioavailability of bedaquiline given as whole tablets or suspended (dissolved) in water.

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IMPAACT p1108

5 Jun 2018

A phase I/II trial to determine the optimal and safe dose of bedaquiline in HIV-infected and uninfected children with MDR-TB.

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MDR PK 2

5 Jun 2018

Building on the data, experience, and clinical platform of MDRPK1, this study seeks to evaluate the pharmacokinetics and safety of model-optimized doses of the key second-line antiTB medications levofloxacin, moxifloxacin, and linezolid in children treated for MDR-TB.

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MDR PK 1

5 Jun 2018

This study of the pharmacokinetics and safety of routine doses of existing second-line antiTB drugs in HIV-infected and uninfected children, was the first study of its kind, in some cases generating some of the only data on the pharmacokinetics and safety of these medications in children with TB. Completed in 2016.

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Otuska 232/233

5 Jun 2018

Industry sponsor-funded (Otuska, Japan) Phase 1 (232) and Phase 2 (233) trials which seek to characterize the pharmacokinetics and safety of delamanid in children with multidrug-resistant (MDR) TB (TB).

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