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.

BACKGROUND: Current WHO MBMDT regimen has largely been successful in treating leprosy patients since 1984, when it was implemented worldwide. According to clinical presentation, pauci and multibacillary leprosy, the regimen is also given for 6 or 12 months. However, this regimen has its limitations, such as incomplete bacterial clearance, prolonged treatment duration and poor patient compliance, necessitating administration of alternative and more effective regimens. Secondly, there is a subset of patients who are highly bacillated and continue to harbour viable bacilli even after treatment and thus continue transmission. We present the protocol of WHOMDT vs. monthly regimen of rifampicin, moxifloxacin and clarithromycin (RMC), a randomised clinical trial designed to test the efficacy of the RMC regimen in the management of multibacillary leprosy.

METHODS AND ANALYSIS: MB MDT vs RMC clinical trial is multicentric which will be conducted in accordance with the CONSORT guidelines in The Leprosy Mission Trust India's tertiary care hospitals at Delhi, Uttar Pradesh, West Bengal and Chhattisgarh. Naive MB leprosy patients who consent to participate will be randomly allocated to receive 12 months of WHO MB MDT or a monthly regimen of rifampicin, moxifloxacin and clarithromycin. The primary objective will be to evaluate the efficacy of monthly RMC regimen compared to the WHOMBMDT in treating multibacillary leprosy. Molecular viability assay will be used to assess the efficacy of the regimen. Monitoring of adverse events will be closely done.

ETHICS AND DISSEMINATION: Results will be submitted for publication in peer-reviewed journals. Ethical approval has been obtained from The Leprosy Mission Trust India's ethics committee (TLMTI/EC/C-69). This study is registered at Clinical Trials Registry-India (CTRI) - CTRI/2024/03/064435.