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

Bern-Thomas Nyang'wa
Purpose of study
Purpose of study

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...

  • Concept
  • Protocol & ERB
  • Implementation
  • Completion
  • Archived

Study timeline

  • Formal working group, expert panel, advisory body dissemination added by Bern-Thomas Nyang'wa

    24th September 2018

    Participation 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

     
  • Publication added by Kim West

    26th July 2016
    Resistance to second-line drugs in multidrug-resistant tuberculosis Nyang'wa, Bern-Thomas – Elsevier BV (2013)
     
  • Publication added by Kim West

    26th July 2016
    Principles for designing future regimens for multidrug-resistant tuberculosis Brigden, Grania – WHO Press (2013)
     
  • Publication added by Kim West

    26th July 2016
    Mortality Rates above Emergency Threshold in Population Affected by Conflict in North Kivu, Democratic Republic of Congo, July 2012–April 2013 Carrión Martín, Antonio Isidro – Public Library of Science (PLoS) (2014)
     
  • Formal working group, expert panel, advisory body dissemination added by Kim West

    26th July 2016

    WHO 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

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Publications

  • Principles for designing future regimens for multidrug-resistant tuberculosis
    Brigden, Grania "–" WHO Press "(2013)"
  • Resistance to second-line drugs in multidrug-resistant tuberculosis
    Nyang'wa, Bern-Thomas "–" Elsevier BV "(2013)"
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