From Tuberculosis › Chapter 10: Treatment of multidrug-resistant and rifampicin-resistant tuberculosis · Médecins Sans Frontières, Current online edition, 2026
Guidance on using experimental MDR/RR-TB treatment regimens under operational research protocols.
- Issuer
- Médecins Sans Frontières
- Edition
- Current online edition, 2026
- Audience
- Clinicians, TB programme managers, researchers
- Evidence
- Expert consensus with reference to clinical trial evidence
- Reviewed
- 22 Oct 2026 · GMJ
What this guideline says
GMJ summary
This section of the MSF Tuberculosis guideline describes the conditions under which patients with multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) may be treated with short treatment regimens (STRs) under operational research conditions, distinct from standard STRs described elsewhere in the guideline. The guidance emphasises that all operational research findings should be published regardless of results to complement clinical trial data.
Operational research requires specific safeguards including a study protocol with defined inclusion/exclusion criteria, regimen composition, monitoring schedule with 12-month post-treatment follow-up, a treatment guide, informed consent processes, ethics committee and Ministry of Health approval, and a pharmacovigilance system with active tuberculosis drug-safety monitoring and management (aDSM). Study protocol templates are available from the Global Drug-resistant TB Initiative (GDI) and WHO.
The BPaLC regimen (6Bdq-Pa-Lzd-Cfz) is provided as an example of a treatment regimen that can be used to treat fluoroquinolone-resistant MDR/RR-TB, but only under operational research conditions with appropriate ethical and monitoring frameworks in place.
Key points
For clinicians — doses and thresholds as stated in the guideline
- Patients with MDR/RR-TB can be treated with short treatment regimens (STRs) under operational research conditions, distinct from standard STRs
- Operational research requires a study protocol identifying inclusion/exclusion criteria, regimen composition, and monitoring schedule including 12-month post-treatment follow-up
- A patient informed consent process is mandatory for operational research
- Approval from an ethics committee and the Ministry of Health is required before implementation
- A pharmacovigilance system with active tuberculosis drug-safety monitoring and management (aDSM) must be in place
- The BPaLC regimen (6Bdq-Pa-Lzd-Cfz) can be used to treat fluoroquinolone-resistant MDR/RR-TB under operational research conditions only
- All operational research results should be published regardless of findings to complement clinical trial data
- Study protocol templates are available from the Global Drug-resistant TB Initiative (GDI) and WHO
From the guideline
Verbatim
“Whatever the findings of the operational research, the results should be published as they may complement findings of clinical trials.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As Editor-in-Chief of the Georgian Medical Journal and Chair of the Public Health Institute of Georgia, I recognise the critical importance of this guidance for our region where drug-resistant tuberculosis remains a significant public health challenge. The framework for operational research outlined here provides a pathway for Georgian clinicians to access novel regimens like BPaLC for fluoroquinolone-resistant cases whilst maintaining patient safety through rigorous ethical oversight and pharmacovigilance. I would particularly stress to local clinicians that the BPaLC regimen must only be used under operational research conditions with full ethics committee approval and active drug-safety monitoring—it is not for routine programmatic use. The main implementation challenge for Georgia will be ensuring that our national TB programme has the capacity for 12-month post-treatment follow-up and functional aDSM systems before embarking on such operational research, though our experience with programmatic management of drug-resistant TB provides a foundation to build upon.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 22 Oct 2026
Applicability
Georgia and the South Caucasus
For Georgia and the South Caucasus, this guidance is highly relevant as the region continues to face challenges with drug-resistant tuberculosis. National TB programmes considering implementation of novel regimens like BPaLC for fluoroquinolone-resistant cases would need to ensure capacity for operational research frameworks, including functional ethics committees, established pharmacovigilance systems with aDSM capabilities, and 12-month post-treatment follow-up mechanisms. Programmes would need to assess whether they can meet the stringent requirements for informed consent, protocol adherence, and data publication before adopting experimental regimens outside of standard treatment algorithms.
Questions this guideline answers
Quick answers
What is the difference between STRs under operational research and standard STRs?
STRs used in operational research conditions are distinct from the standard STRs described in Section 10.2.1 of the MSF guideline. They are experimental regimens that require specific ethical approvals, research protocols, and enhanced monitoring, whereas standard STRs are established treatment regimens used in routine programmatic conditions.
What are the minimum requirements to implement operational research for MDR/RR-TB treatment?
The requirements include: a study protocol with inclusion/exclusion criteria, regimen composition and monitoring schedule with 12-month post-treatment follow-up; a treatment guide; patient informed consent process; approval from ethics committee and Ministry of Health; and a pharmacovigilance system with active tuberculosis drug-safety monitoring and management (aDSM).
When can the BPaLC regimen be used?
The BPaLC regimen (6Bdq-Pa-Lzd-Cfz) can be used to treat fluoroquinolone-resistant MDR/RR-TB, but only under operational research conditions with all required safeguards in place. It should not be used in routine programmatic settings.
Where can I find templates for operational research protocols?
Study protocol templates are available from the Global Drug-resistant TB Initiative (GDI) and WHO. These templates provide standardised frameworks for conducting operational research on MDR/RR-TB treatment regimens.
Related on GMJ
Interconnected resources
Drugs A–Z
Quality & accreditation
- ASF Laboratory — Standard 1 — Governance & Document Control
- ASF Laboratory — Standard 6 — Pre-Examination: Specimen Pathway
- ASF Laboratory — Standard 7 — Examination: Process & Safety
- ASF Laboratory — Standard 8 — Post-Examination: Reporting & Critical Values
- ASF Hospital — Standard 4 — Care & Treatment
- ASF Hospital — Standard 7 — Governance & Management
Same guideline
- Treatment Regimens in Programmatic Conditions for Multidrug-Resistant and Rifampicin-Resistant Tuberculosis — MSF TuberculosisChapter 10: Treatment of multidrug-resistant and rifampicin-resistant tuberculosis
- Treatment of Multidrug-Resistant and Rifampicin-Resistant Tuberculosis: Introduction — MSF TuberculosisChapter 10: Treatment of multidrug-resistant and rifampicin-resistant tuberculosis
- Patient monitoring — MSF TuberculosisChapter 9: Treatment of drug-susceptible tuberculosis
- Adjunctive Therapy in Drug-Susceptible Tuberculosis — MSF TuberculosisChapter 9: Treatment of drug-susceptible tuberculosis
- Special situations in drug-susceptible tuberculosis treatment — MSF TuberculosisChapter 9: Treatment of drug-susceptible tuberculosis
- Alternative treatment regimens for drug-susceptible tuberculosis — MSF TuberculosisChapter 9: Treatment of drug-susceptible tuberculosis
Other guidelines on this topic
- Treatment Regimens in Programmatic Conditions for Multidrug-Resistant and Rifampicin-Resistant Tuberculosis — MSF Tuberculosis
- Treatment of Multidrug-Resistant and Rifampicin-Resistant Tuberculosis: Introduction — MSF Tuberculosis
- Patient monitoring — MSF Tuberculosis
- Adjunctive Therapy in Drug-Susceptible Tuberculosis — MSF Tuberculosis
- Special situations in drug-susceptible tuberculosis treatment — MSF Tuberculosis
- Issuer
- Médecins Sans Frontières
- Guideline
- Tuberculosis
- Chapter
- Chapter 10: Treatment of multidrug-resistant and rifampicin-resistant tuberculosis
- Type
- Clinical guideline (chapter)
- Edition
- Current online edition, 2026
- Status
- Current
- Published
- 2026-10-14
- Scope
- Section 10.3 of MSF Tuberculosis guideline covering treatment regimens for MDR/RR-TB under operational research conditions
- Audience
- Clinicians, TB programme managers, researchers
- Evidence
- Expert consensus with reference to clinical trial evidence
- Record history
- Created 22 Oct 2026 · updated 22 Oct 2026 · next check Apr 2027
Médecins Sans Frontières. Treatment regimens in operational research conditions. In: Tuberculosis. Section 10.3 of Chapter 10: Treatment of multidrug-resistant and rifampicin-resistant tuberculosis. MSF; 2026. Available from: [URL]GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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