View clinical trials related to Buruli Ulcer.
Filter by:Buruli ulcer (BU) is a skin Neglected Tropical Disease (NTD) that is caused by Mycobacterium ulcerans. It affects skin, soft tissues and bones causing long-term morbidity, stigma and disability. The greatest burden falls on children in sub-Saharan Africa. Treating BU requires 8-weeks with daily rifampicin and clarithromycin, wound care, and sometimes tissue grafting and surgery. Healing can take up to one year. Compliance is challenging due to socioeconomic determinants and may pose an unbearable financial burden to the household. Recent studies led by members of this Consortium demonstrated that beta-lactams combined with rifampicin and clarithromycin are synergistic against M. ulcerans in vitro. Amoxicillin/clavulanate is oral, suitable for treatment in adults and children, and readily available with an established clinical pedigree. Its inclusion in a triple oral BU therapy has the potential of improving healing and shortening BU therapy. The investigators propose a single blinded, randomized, controlled open label non-inferiority phase II, multi-centre trial in Benin with participants stratified according to BU category lesions and randomized in two oral regimens: (i) Standard [RC8]: rifampicin plus clarithromycin (RC) therapy for 8 weeks; and (ii) Investigational [RCA4]: standard (RC) plus amoxicillin/clavulanate (A) for 4 weeks. At least, a total of 140 patients will be recruited (70 per treatment arm), of which at least 132 will be PCR-confirmed. The primary efficacy outcome will be lesion healing without recurrence and without excision surgery 12 months after start of treatment (i.e. cure). A clinical expert panel assessing the need of excision surgery in both treatment arms will be blinded for treatment allocation in order to make objectives comparisons. Decision for excision surgery will be delayed to 14 weeks after initiation of antibiotic treatment. Secondary clinical efficacy outcomes include recurrence, treatment discontinuation and compliance rates, and the incidence of adverse effects, among others. In addition, two sub-studies will be performed: a pharmacokinetic (PK) analysis and a bacterial clearance study. If successful, this study will create a new paradigm for BU treatment, which could inform changes in WHO policy and practice. This trial may also provide information on treatment shortening strategies for other mycobacterial infections, such as tuberculosis or leprosy.
The project rolls out combined innovative low-tech thermotherapy with heat packs and WHO recommended wound management in a Buruli ulcer (BU)-endemic district of West Africa. It addresses three key areas of considerable clinical and public health importance in the region: - to better help people managing the disabling disease BU that primarily affects children in West Africa - to implement WHO recommended general wound management for all types of wounds with tools available at the peripheral level of the health care system - to prevent systemic life threatening sequelae (e.g. sepsis and rheumatic fever) and permanent local damage (e.g. motor and sensory disability) by early recognition and treatment of wounds at the community level. The project translates available research findings already validated on the secondary health care level into clinical practice at the periphery (primary health care level). The string of the investigator's previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary skills, tools and documents to immediately proceed into practical community application. Operational endpoints are - coverage and quality of WHO recommended wound management training of health care personnel at the primary health care level (health posts); - coverage, success rate and quality of care for patients with BU and other wounds; denominator controlled at health post level and high-quality Health and Demographic Surveillance Systems (HDSS) data. The project is embedded into a stable multidisciplinary working environment at Côte d'Ivoire, including an HDSS with a longstanding record of partnership and successful community-based operational research. The project builds on the principles laid out by the Sustainable Development Goals (SDGs) and Universal Health Coverage (UHC) and - targets all patients with a broken down skin barrier independent of the cause (patient centred health care) - brings diagnosis and treatment close to the community - educates and trains both community members and health care workers - measures the health intervention outcome The project is fully in line with the new integrated strategy for the skin NTDs of WHO's Department of Control of NTDs (WHO/NTD).