Former Buruli Ulcer Patients’ Experiences and Wishes May Serve as a Guide to Further Improve Buruli Ulcer Management

Velink, Anita; Woolley, Rebecca J.; Phillips, Richard Odame; Abass, Kabiru Mohammed; Werf, Tjip S. van der; Agumah, Emmanuel; Zeeuw, Janine de; Klis, Sandor; Stienstra, Ymkje

doi:10.1371/journal.pntd.0005261

Cited by 24 publications

(21 citation statements)

References 26 publications

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“…16 This study addressed a question that was also deemed important by former patients who prioritised research into treatment that avoided painful injections and had few sideeffects. 28 Age and sex distribution, as well as socioeconomic status and educational level in this study population were all typical for the population affected by Buruli ulcer in west Africa.…”

Section: Discussionmentioning

confidence: 56%

Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial

et al. 2020

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Background Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions. MethodsWe did an open-label, non-inferiority, randomised (1:1 with blocks of six), multicentre, phase 3 clinical trial comparing fully oral RC8 with RS8 in patients with early, limited Buruli ulcer lesions. There were four trial sites in hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè). Participants were included if they were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (caterories I and II) no larger than 10 cm in diameter. The trial was open label, and neither the investigators who took measurements of the lesions nor the attending doctors were masked to treatment assignment. The primary clinical endpoint was lesion healing (ie, full epithelialisation or stable scar) without recurrence at 52 weeks after start of antimicrobial therapy. The primary endpoint and safety were assessed in the intention-to-treat population. A sample size of 332 participants was calculated to detect inferiority of RC8 by a margin of 12%. This study was registered with ClinicalTrials.gov, NCT01659437.

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Section: Discussionmentioning

confidence: 56%

Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial

et al. 2020

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“…Good wound management is required not only for faster and sequelae-free epithelialization of ulcers but also for increased quality of life of patients. BU lesions were previously noticed to be associated with no or limited pain, but recent studies have revealed that many patients actually experience pain after the start of treatment [ 72 , 95 , 96 ]. This pain is most felt during wound dressing change when in many settings, gauze is the only dressing type being used [ 97 ].…”

Section: Importance Of Wound Management In Buruli Ulcermentioning

confidence: 99%

Buruli Ulcer: a Review of the Current Knowledge

et al. 2018

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Purpose of the ReviewBuruli ulcer (BU) is a necrotizing and disabling cutaneous disease caused by Mycobacterium ulcerans, one of the skin-related neglected tropical diseases (skin NTDs). This article aims to review the current knowledge of this disease and challenges ahead.Recent FindingsAround 60,000 cases of BU have been reported from over 33 countries between 2002 and 2017. Encouraging findings for development of point-of-care tests for BU are being made, and its treatment is currently in the transition period from rifampicin plus streptomycin (injection) to all-oral regimen. A major recent advance in our understanding of its pathogenesis has been agreement on the mechanism of action of the major virulence toxin mycolactone in host cells, targeting the Sec61 translocon during a major step in protein biogenesis.SummaryBU is distributed mainly in West Africa, but cases are also found in other parts of the world. We may be underestimating its true disease burden, due to the limited awareness of this disease. More awareness and more understanding of BU will surely contribute in enhancing our fight against this skin NTD.

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“…Shorter treatment would benefit patients by reducing indirect costs and barriers to treatment, and increasing adherence (9, 10, 32). With RIF, a clear dose-response relationship was demonstrated by linear regression with both clinical (swelling grade) and microbiological (CFU) outcome.…”

Section: Discussionmentioning

confidence: 99%

High-dose rifamycins enable shorter oral treatment in a murine model of Mycobacterium ulcerans disease

Omansen

Almeida

Converse

et al. 2018

Preprint

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16Buruli ulcer (BU), caused by Mycobacterium ulcerans, is a neglected tropical skin and soft tissue 17 infection that is associated with disability and social stigma. The mainstay of BU treatment is an 18 eight-week course of 10 mg/kg rifampin (RIF) and 150 mg/kg streptomycin (STR). Recently, the 19 injectable STR has been shown to be replaceable with oral clarithromycin (CLR) for smaller 20 lesions for the last four weeks of treatment. A shorter, all-oral, highly efficient regimen for BU is 21 needed, as the long treatment duration and indirect costs currently burden patients and health 22 based on higher rifamycin doses that are currently being evaluated against tuberculosis in clinical 32 trials could shorten and improve therapy of Buruli ulcer. 33 34 Words: 250/250 35

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Former Buruli Ulcer Patients’ Experiences and Wishes May Serve as a Guide to Further Improve Buruli Ulcer Management

Cited by 24 publications

References 26 publications

Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial

Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial

Buruli Ulcer: a Review of the Current Knowledge

High-dose rifamycins enable shorter oral treatment in a murine model of Mycobacterium ulcerans disease

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