10.3 Treatment regimens in operational research conditions

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    Patients with MDR/RR-TB can be treated under operational research conditions with STRs (distinct from the STRs described in Section 10.2.1).

    Whatever the findings of the operational research, the results should be published as they may complement findings of clinical trials.

    10.3.1 Operational research conditions

    The requirements for conducting operational research include:  

    • A study protocol identifying the inclusion/exclusion criteria, regimen composition, monitoring schedule including 12-month post-treatment follow-up 
    • A treatment guide 
    • A patient informed consent process 
    • The approval of an ethics committee and the Ministry of Health 
    • A pharmacovigilance system (active tuberculosis drug-safety monitoring and management, aDSM[1]Citation 1.World Health Organization. Active tuberculosis drug-safety monitoring and management (aDSM). Framework for implementation. WHO, Geneva, 2015. https://iris.who.int/bitstream/handle/10665/204465/WHO_HTM_TB_2015.28_eng.pdf?sequence=1)

    Study protocol templates are available from the Global Drug-resistant TB Initiative (GDI)aCitation a.GDI template available at:
    https://www.stoptb.org/sites/default/files/imported/page/oldweb/wg/mdrtb/assets/documents/GDI_OR_generic_protocol_final.pdf    and WHObCitation b.WHO template available at:
    https://tdr.who.int/docs/librariesprovider10/shorrt-initiative/shorrt-generic-protocol-june2020_en.pdf?sfvrsn=df85f6c1_3    .

    10.3.2 Treatment regimens 

    The BPaLC (6Bdq-Pa-Lzd-Cfz)[2]Citation 2.Nyang'wa, Bern-Thomas, Da Costa, Erin et al. Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): an open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial. The Lancet Respiratory Medicine, Volume 12, Issue 2, 117 - 128 February 2024.https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(23)00389-2/fulltext regimen is an example of a treatment regimen that can be used to treat fluoroquinolone-resistant MDR/RR-TB, under operational research conditions only.

     

     
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