TB- PRACTECAL: A randomised, controlled, open-label, phase II-III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug resistant tuberculosis.
Principal investigator
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Locations
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Topic
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Methodology
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ReferenceOCA015-02
Identify regimens containing bedaquiline and pretomanid for further evaluation based on safety and efficacy outcomes after 8 weeks of treatment. And to evaluate the safety and efficacy of the investigational regimens containing bedaquiline and pre...
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Concept
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Protocol & ERB
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Implementation
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Completion
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Archived
Study timeline
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Formal working group, expert panel, advisory body dissemination added by Bern-Thomas Nyang'wa
24th September 2018Participation in technical consultation on Advances in Clinical Trial Design for Development of New TB Treatments, Glion-sur-Montreux, Switzerland on 14-16 March 2018. The report on the Technical Consultation on Advances in Clinical Trial Design for Development of New TB Treatments (published on 19th September 2018) available here: http://www.who.int/tb/publications/2018/WHO-CDS-TB-2018.17-eng.PDF?ua=1
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Publication added by Kim West
26th July 2016 -
Publication added by Kim West
26th July 2016 -
Publication added by Kim West
26th July 2016 -
Formal working group, expert panel, advisory body dissemination added by Kim West
26th July 2016WHO TB New Drugs Task Force. Advising WHO tuberculosis new drugs task force in formulation of revised guidelines, on basis of published recommendations around design of current trial.
Documents
Publications
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Principles for designing future regimens for multidrug-resistant tuberculosisBrigden, Grania "–" WHO Press "(2013)"
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Resistance to second-line drugs in multidrug-resistant tuberculosisNyang'wa, Bern-Thomas "–" Elsevier BV "(2013)"