MDR/RR-TB in Adults Aged 14 or Older When Extended BPaL Does Not Achieve Sputum Culture Conversion
This protocol addresses pulmonary multidrug- or rifampicin-resistant tuberculosis (with or without fluoroquinolone resistance) in patients aged 14 years and older who are not pregnant or breastfeeding — specifically when a prior extended regimen has not met its required culture conversion targets.
The preceding step used an extension of the BPaL regimen — bedaquiline, pretomanid, linezolid — extended to a total of 9 months (39 weeks), with all medicines continued throughout. This protocol is triggered when that extended course fails to achieve its required goals: sputum culture conversion soon after month 4, with month 5 and month 6 cultures remaining negative.
Patients are adults or adolescents aged 14 years or older with pulmonary MDR/RR-TB, with or without additional fluoroquinolone resistance. This regimen is not indicated during pregnancy.
At this stage, a longer individualized MDR-TB regimen — built from a priority grouping of second-line medicines — is used. The approach draws agents from multiple priority groups based on their likelihood of effectiveness, with the composition determined individually. The complete grouping, selection criteria, and sequencing are set out in the full protocol.
Goal: Sputum culture conversion to negative — monitored monthly
- WHO suggests the use of the 6-month treatment regimen composed of bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin (BPaLM) rather than 9-month or longer (18-month) regimens in MDR/RR-TB patients.
- Adults and adolescents aged 14 years and older.
- It is not recommended during pregnancy.
- 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.