Protocol of a comparative multicentric non inferiority clinical trial of WHO MBMDT with a new monthly chemotherapy regimen containing rifampicin, moxifloxacin and clarithromycin (RMC) on multibacillary patients from India

Key Points

• This trial aims to evaluate the non-inferiority of a new chemotherapy regimen compared to WHO MBMDT in treating multibacillary patients.
• Multicentric clinical trial design
• Involvement of multibacillary patients from India
• Administration of a new regimen containing rifampicin, moxifloxacin, and clarithromycin
• Ethical approval obtained from The Leprosy Mission Trust's ethics committee
• Registered at Clinical Trials Registry-India
• Results will be submitted for publication in peer-reviewed journals
• Specific outcomes and data will be disclosed upon publication