Comparison of 8 weeks standard treatment (rifampicin plus clarithromycin) vs. 4 weeks standard plus amoxicillin/clavulanate treatment [RC8 vs. RCA4] to shorten Buruli ulcer disease therapy (the BLMs4BU trial): study protocol for a randomized controlled multi-centre trial in Benin

Background Buruli ulcer (BU) is a neglected tropical disease caused by Mycobacterium ulcerans that affects skin, soft tissues, and bones, causing long-term morbidity, stigma, and disability. The recommended treatment for BU requires 8 weeks of daily rifampicin and clarithromycin together with wound care, physiotherapy, and sometimes tissue grafting and surgery. Recovery can take up to 1 year, and it may pose an unbearable financial burden to the household. Recent in vitro studies demonstrated that beta-lactams combined with rifampicin and clarithromycin are synergistic against M. ulcerans. Consequently, inclusion of amoxicillin/clavulanate in a triple oral therapy may potentially improve and shorten the healing process. The BLMs4BU trial aims to assess whether co-administration of amoxicillin/clavulanate with rifampicin and clarithromycin could reduce BU treatment from 8 to 4 weeks. Methods We propose a randomized, controlled, open-label, parallel-group, non-inferiority phase II, multi-centre trial in Benin with participants stratified according to BU category lesions and randomized to two oral regimens: (i) Standard: rifampicin plus clarithromycin therapy for 8 weeks; and (ii) Investigational: standard plus amoxicillin/clavulanate for 4 weeks. The primary efficacy outcome will be lesion healing without recurrence and without excision surgery 12 months after start of treatment (i.e. cure rate). Seventy clinically diagnosed BU patients will be recruited per arm. Patients will be followed up over 12 months and managed according to standard clinical care procedures. Decision for excision surgery will be delayed to 14 weeks after start of treatment. Two sub-studies will also be performed: a pharmacokinetic and a microbiology study. Discussion If successful, this study will create a new paradigm for BU treatment, which could inform World Health Organization policy and practice. A shortened, highly effective, all-oral regimen will improve care of BU patients and will lead to a decrease in hospitalization-related expenses and indirect and social costs and improve treatment adherence. This trial may also provide information on treatment shortening strategies for other mycobacterial infections (tuberculosis, leprosy, or non-tuberculous mycobacteria infections). Trial registration ClinicalTrials.gov NCT05169554. Registered on 27 December 2021

Ethno-botanical study of the African star apple (<it>Chrysophyllum albidum</it> G. Don) in the Southern Benin (West Africa)

<p>Abstract</p> <p>Background</p> <p>In addition to plant species biology and ecology, understanding the folk knowledge systems related to the use of plant species and how this knowledge system influences the conservation of plant species is an important issue in the implementation of sustainable strategies of biodiversity conservation programs. This study aimed at providing information on the use and local knowledge variation on <it>Chrysophyllum albidum</it> G. Don a multipurpose tree species widely used in southern Benin.</p> <p>Methods</p> <p>Data was collected through 210 structured interviews. Informants were randomly selected from ten villages. The fidelity level and use value of different plant parts of <it>C. albidum</it> were estimated. The variation in ethnobotanical knowledge was assessed by comparing the use value between ethnic, gender and age groups. In order to assess the use pattern of the different plant parts in folk medicine, a correspondence analysis was carried out on the frequency citation of plant parts.</p> <p>Results</p> <p>Four categories of use (food, medicine, firewood and timber) were recorded for <it>C. albidum</it>. With respect to the different plant parts, the fleshy pulp of the African star apple fruit showed high consensus degree as food among the informants. Fifteen diseases were reported to be treated by the different parts of <it>C. albidum</it> in the region. Correspondence analysis revealed the specificity of each part in disease treatment. There was no significant difference among ethnic groups regarding the ethno-botanical use value of <it>C. albidum</it>. However, significant difference existed between genders and among age groups regarding the knowledge of the medical properties of this species.</p> <p>Conclusions</p> <p><it>C. albidum</it> is well integrated in the traditional agroforestry system of the southern Benin. Despite its multipurpose character, this species remains underutilized in the region. Considering the current threat of habitat degradation, action is needed in order to ensure the long term survival of the species and local communities’ livelihoods.</p