Pulmonary MDR/RR-TB in Children Under 14 or Pregnant and Breastfeeding Women — When the 6-Month BDLLfxC Regimen Falls Short
This protocol covers the specific situation where pulmonary multidrug- or rifampicin-resistant TB (with or without fluoroquinolone resistance) is being treated in a child under 14 years of age or a woman who is pregnant or breastfeeding, and the initial 6-month regimen has not achieved the expected culture conversion milestones.
Clinical Scenario
Pulmonary MDR/RR-TB, with or without fluoroquinolone resistance, in a patient who is either aged below 14 years or is pregnant or breastfeeding. The BDLLfxC regimen (or BDLLfx or BDLC, depending on fluoroquinolone susceptibility) was selected because the patient was unable to benefit from the standard BPaLM regimen — for example, due to restricted access to pretomanid, young age, or pregnancy.
Previous Regimen — Targets Not Met
The 6-month (24-week) BDLLfxC regimen (or BDLLfx / BDLC where applicable) was the initial treatment. The expected goals — sputum culture conversion and satisfactory clinical and radiological response by month 4, with month 5 and 6 cultures confirmed negative — were not reached, indicating the need to escalate to this protocol.
Next Step (Partial Overview)
When culture and clinical response targets have not been met on the standard-duration regimen, an extension of the same regimen is the approach. The full protocol details the precise conditions, duration of extension, and decision criteria that determine whether and how to proceed.
Treatment goals: Culture conversion soon after month 4, with month 5 and 6 cultures confirmed negative.
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.
- The expected duration of the BDLLfxC, BDLLfx and BDLC regimens is 6 months (24 weeks) but this may be extended to 9 months (36 weeks) if necessary.
- If the month 5 and 6 culture results remain persistently positive, treatment failure should be suspected, particularly if the patient has had suboptimal adherence to treatment or shows other signs of poor clinical or radiological response to treatment.