Evaluation of High Dose Rifampicin and Dialkylcarbamoyl chloride (DACC)-coated dressings to improve outcomes in Mycobacterium ulcerans disease - Trial PACTR202011867644311

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Summary

BACKGROUND Buruli ulcer is a neglected infectious disease (NID) caused by Mycobacterium ulcerans (Mu). It occurs mainly in rural parts of West Africa including Ghana. Treatment with antibiotics, rifampicin with either streptomycin or clarithromycin, has transformed management of Buruli ulcer but it is given for 8 weeks and the rate of healing is highly variable even in patients with seemingly similar lesions. We propose using a high dose rifampicin to be taken for a shorter period and Dialkylcarbamoyl chloride (DACC)-coated wound dressings to improve on the rate of clearance of Mycobacterium ulcerans thereby improving on the management of Buruli ulcer disease.Primary Objective• Compare the time to clearance of viable Mycobacterium from wounds of patients treated with high-dose rifampicin and DACC dressings (HR-DACC) to those receiving standard dose rifampicin and DACC dressings (SR-DACC). Secondary Objectives• Assess impact of high-dose Rifampicin and DACC dressings on the rate of wound healing • Assess the rate of paradoxical reactions between dressing groups• Asses the recurrence rate in both groups• Evaluate the incremental costs and cost-effectiveness of high dose Rifampicin vs standard dose Rifampicin STUDY DESIGN: A prospective randomised open-blinded end-point (PROBE) study of High Dose (20mg/kg) Rifampicin+ standard dose clarithromycin (15mg/kg) administered daily for four weeks and Dialkylcarbamoyl chloride (DACC)-coated dressings to be changed every other day for eight weeks. This will be compared with Standard dose Rifampicin (10mg/kg) + standard dose clarithromycin (15mg/kg)administered daily and Dialkylcarbamoyl chloride (DACC)-coated dressings changed every other day for eight weeks.

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