Evaluation of a nitric oxide generating dressing (EDX110) to improve management of Buruli ulcer disease (BURULINOX) - Trial PACTR201812819039144
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Study Focus
Sponsor & Location
Kumasi Centre for Collaborative Research
EDCTP
Timeline & Enrollment
Phase 3
Aug 06, 2021
Jan 01, 1900
Summary
BACKGROUNDBuruli 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 the 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 novel nitric oxide-generating wound dressing to rapidly kill Mu and enhance healing. Primary Objective:A comparison of the rate of healing of lesions between EDX110 with oral rifampicin and clarithromycin (“EDX-RC”) and vaseline gauze dressings with oral rifampicin and clarithromycin (“VG-RC”)Secondary Objective:• To compare the tolerability of the two dressings• To evaluate the relationship between treatment, the immune profile and healing in each treatment arm• To compare the rate of bacterial killing in each treatment armExploratory Objectives • To evaluate the quality and cosmetic appearance of healing• To document healing in lesions that have not ulcerated within 2 weeks of the start of treatment.• To document recurrence rate and paradoxical reactions in the two treatment armsIn addition, the trial aims • To build capacity for treatment and research in Ghana• Training/ Mentoring of a cadre of Junior Scientists (PhD/Master students/Postdoc/Clinical scientists)• Training of village volunteers in the use and application of the dressing materialsSTUDY DESIGN A prospective randomised open-blinded end-point (PROBE) study of either rifampicin 10mg/kg and clarithromycin 15mg/kg daily AND NOx-generating gel dressing (EDX) applied on alternate days to the wound (RC-EDX) or rifampicin 10mg/kg and clarithromycin 15mg/kg daily AND vaseline gauze dressings applied daily to the wound (RC) representing the current standard of care.
ICD-10 Classifications
Data Source
Pan Africa Clinical Trials Registry
PACTR201812819039144
Non-Device Trial