A randomized clinical trial of two single-dose treatments for paucibacillary leprosy

We compared 2 single-dose regimens for the treatment of paucibacillary leprosy in a randomized clinical trial in Zaïre. The regimens were: C2 (rifampicin 40 mg/kg and 1200 mg clofazimine once) and C4 (rifampicin 40 mg/kg, clofazimine 100 mg, DDS 100 mg and ethionamide 500 mg once). An analysis of the results of patients enrolled between May 1987 and December 1988, with a maximum follow-up of 4 years, is presented. A total of 622 patients were enrolled and 14 paucibacillary and 1 multibacillary relapses occurred. The overall paucibacillary relapse rate was 2.4 per 100 person years. This relapse rate was higher for older patients as well as for patients with 3 or more lesions. The probability of cure at 3 years is 0.816 for C2 and 0.823 for C4, the difference not being statistically significant. The probability of cure at 3 years with either regimen is higher for patients with 1 or 2 lesions (0.872) than for patients with 3 or more lesions (0.787), and it is higher for patients with a bacterial index of 0 (0.831) than for patients with a bacterial index of 1 (0.699). These results are compared to other studies. We also discuss the potential of single-dose treatment regimens for paucibacillary leprosy.