Treatment outcome of a shorter regimen containing clofazimine for multidrug-resistant tuberculosis: a randomized control trial in China

BACKGROUND: The emergence of multidrug-resistant tuberculosis (MDR-TB) poses a serious obstacle to global TB control programmes. METHODS: We carried out a prospective, randomised multicenter study in China focused on the potential of shorter regimen containing clofazimine (CFZ) for the treatment of MDR-TB. 135 MDR-TB cases met eligibility requirements and were randomly stratified into control group or experimental group. Patients in the control group received 18-month treatment regimen, whereas patients in the experimental group received 12-month treatment regimen containing CFZ. RESULTS: At the completion of treatment period, the difference in sputum-culture conversion between the experimental group and the control group was not significant. Notably, by the end of the 3-month treatment, 68.7% patients receiving experimental regimen had sputum-culture conversion as compared with 55.9% of those receiving control regimen; this was a significant difference, suggesting an early sputum conversion (P=0.04). 67 adverse events were reported in 56 patients in this study, including 32 in the control group and 35 in the experimental group, respectively. No significant difference in the overall incidence of adverse events was observed between the two groups. CONCLUSION: The MDR-TB patients initiated with the shorter regimen containing CFZ have a comparable successful outcome rate when compared to those with the standard regimen. The patients assigned in the experimental group achieve more rapid sputum culture conversion, reflecting the superior antimicrobial activity against MDR-TB.