Explanation for the choice of comparators {6b}
This dose-finding study is small and does not contain a classical comparator arm. 15 participants will receive DLM, BDQ, and MOX without DZD, but this is not powered to show the effect of adding DZD, unless the core regimen or DZD is much more effective or much less effective than anticipated, although this arm does provide data on a ‘0mg’ dose of DZD for the exposure modelling analysis. The intention is to provide data to set up an exposure-response model for DZD on the basis of a backbone regimen composed of the 2BDQ, a diarylquinoline compound, is the first new anti-TB drug approved after 40 years by the FDA, also specifically, as part of a combination therapy for the treatment of MDR-TB. It is approved and part of the national standard recommended treatment regimen for RR- and MDR-TB in South Africa [DLM, a nitroimidazole, represents a promising new drug for the treatment of MDR-TB. It has received regulatory approvals in several countries and has been recommended by the WHO for the treatment of MDR-TB in specific cases [MXF is a fluoroquinolone (FQ). FQ are a mainstay of MDR-TB treatment and MXF, is considered as one of the most potent drug in second-line MDR-TB therapy as recently reviewed by the WHO. Furthermore, MXF has an excellent safety profile according to data on its long-term use.