A randomised controlled trial assessing the effect of adding clarithromycin to rifampicin, ofloxacin and minocycline in the treatment of single lesion paucibacillary leprosy in Agra District, India.
AIM: To assess if there is any additional short and long-term effect of adding clarithromycin to rifampicin, ofloxacin and minocycline (ROM), the combination here after called C-ROM, in treating single lesion PB leprosy detected in the field.
METHODS: 300 patients, detected on active search in Agra district, who had single lesion leprosy but no nerve thickening, were randomly allocated (using random number table) to two treatment groups, 151 to ROM and 149 to C-ROM. All th patients were given single dose of ROM or C-ROM and followed up every 6 months for disease status, cure rate, reaction and relapse. Survival analysis was used to compare relapse rate.
RESULTS: The cure rate at 2 years was 93.1% in ROM and 91.4% in C-ROM group. By this time three relapses had occurred in the ROM group while two patients were found to have relapsed in the C-ROM group. Thus, there was no statistical difference in relapse rates (2.1% vs. 1.41%, P = 0.287) in the two groups. Long term observations over 3-5 years revealed nine relapses (five in ROM, four in C-ROM) giving relapse rate of 1.05/100 Person years in ROM and 0.90/100 person years in C-ROM group--again no significant difference was observed (P = 0.87).
CONCLUSION: The study shows that addition of clarithromycin to ROM does not significantly improve the efficacy as measured in terms of cure rates and relapse rates in single skin lesion leprosy patients.