Linezolid Dosing Strategies in Drug-Resistant TB

The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study also measured the level of LZD and BDQ in the participants' blood.

When the study was designed, there was currently no "standard of care" or single standardized treatment regimen recommended for everyone with drug resistant-tuberculosis (DR-TB). Current DR-TB treatments were not well tolerated and often had side effects. There was a need to identify drugs with enough anti-TB activity (treatment against TB) and good safety profiles that could improve outcomes in the treatment of DR-TB.

The main purpose of this study was to evaluate the efficacy and tolerability of a new shorter course anti-TB treatment regimen that compared two dosing strategies of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). As a secondary aim, the study assessed the safety (the level and type of side effects from a drug or treatment) of the combination of these drugs.

Everyone in the study took BDQ, DLM, and CFZ once a day for the entire treatment period. The difference between the two treatment groups in the study was in how participants took the fourth drug: LZD. Participants in group A took one dose of LZD once a day for the entire treatment period. Participants in group B took a higher dose of LZD once a day for 4 weeks and then took that higher dose of LZD just three times a week for the rest of the treatment period.