Project: Evaluation of a nitric oxide generating dressing (EDX) to improve management of Buruli ulcer disease

Acronym	BuruliNox (Reference Number: TMA2016SF-1509)
Duration	01/04/2018 - 31/03/2023
Project Topic	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 novel nitric oxide-generating wound dressing to rapidly kill Mu and enhance healing. As there is a lack of critical mass of scientists in NID we also propose to expand capacity through this research programme. Scientific Aims: The primary objective of the study is to determine the ability of the nitric oxide releasing (NOx) dressing combined with oral rifampicin and clarithromycin to shorten the time to complete healing of Buruli lesions by comparison with the same antibiotic therapy combined with standard dressings. Developmental Aims: Embedded in the scientific proposal, there are strong development aims to be delivered by training world class research scientists using the train the trainer approach, which builds upon previous work to enable progression to the next level. The core aim is to spread expertise in research methodologies, statistics, research governance and administration, and specialized diagnostics and laboratory skills. STUDY 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 current standard of care. Primary endpoint: Comparison of the time to complete healing of lesions. Secondary End points: Comparison of the time to complete killing of M. ulcerans; comparison of proportion of patients expressing T cell markers associated with healing at week 4 and 8; comparison of the tolerability of the wound dressings; comparison of the recurrence rate; number of junior scientists trained. EXPECTED IMPACT If treatment with topical NOx combined with oral antibiotics causes more rapid killing of Mu and enhances healing, treatment will be shortened and made more convenient for patients. This will improve the delivery of treatment. The study will likely produce high impact scientific papers. This project will allow the Fellow to develop his ability to initiate, design, plan and execute a complex clinical research programme through collaboration with others and there will be a significant impact on the pool of trained junior scientists.
Network	EDCTP2
Call	Senior Fellowships 2016

Project partner

Number	Name	Role	Country
1	Kwame Nkrumah University of Science and Technology	Coordinator	Ghana