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

  • 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

     
  • Study coordinator or Topic Holder changed by barbara N

    13th September 2018
  • External Policy impact added by Bern-Thomas Nyang'wa

    15th November 2016

    Invited to participate in the WHO Target Regimens for TB consensus meeting see report on link and this resulted in the following guidance from WHO

     
  • Principal investigator changed by Kim West

    8th October 2016

    Changed to “Bern-Thomas Nyang'wa”

  • 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.

     
  • Title changed by Kim West

    26th July 2016

    Changed to “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.”

  • Concept
    26th July 2016
  • Study created

    26th July 2016

    Originally titled 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. (short name: TB-PRACTECAL)

Documents

No documents uploaded

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)"