MDR/RR-TB in Children Under 14 or During Pregnancy and Breastfeeding: What to Do When Extended Regimen Fails Culture Conversion

This protocol addresses pulmonary multidrug- or rifampicin-resistant TB (MDR/RR-TB), with or without fluoroquinolone resistance, specifically in patients aged under 14 years or who are pregnant or breastfeeding — and whose prior extended treatment did not achieve the required culture conversion targets.

Clinical Scenario

MDR/RR-TB (with or without fluoroquinolone resistance) in a patient who is either aged below 14 years or is pregnant or breastfeeding — populations for whom access to certain standard MDR-TB options is restricted or contraindicated.

Previous Treatment — Failure Condition

Prior therapy consisted of the extended BDLLfxC (or BDLLfx / BDLC) regimen. That regimen did not achieve the required goals: culture conversion soon after month 4, with months 5 and 6 cultures remaining negative. This protocol is the next step taken after that shortfall.

Next Step — Approach (Partial Overview)

The escalated step involves switching to a longer, individualized MDR-TB regimen built from priority-grouped second-line medicines, with a defined set of core agents forming the backbone. The complete composition, sequencing, and duration are detailed in the full protocol.

Treatment goal: Sputum culture conversion to negative, monitored at monthly intervals throughout the course of treatment.

Instant Access to Structured Evidence-Based Regimens

References

WHO suggests the use of a 6-month treatment regimen composed of bedaquiline, delamanid, linezolid (600 mg), levofloxacin, and clofazimine (BDLLfxC) in MDR/RR-TB patients with or without fluoroquinolone resistance.

This short regimen is particularly appropriate for people who are unable to benefit from the currently recommended 6-month BPaLM regimen owing, for example, to restricted access to pretomanid, being aged younger than 14 years, or being pregnant or breastfeeding.

In multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) patients on longer regimens, all three Group A agents and at least one Group B agent should be included to ensure that treatment starts with at least four TB agents likely to be effective, and that at least three agents are included for the rest of the treatment if bedaquiline is stopped.

In multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) patients on longer regimens, the performance of sputum culture in addition to sputum smear microscopy is recommended to monitor treatment response.

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