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Antimicrobial Treatment for Buruli Ulcer Is Effective In Early, Limited Disease NEW YORK -- February 3, 2010 -- Research published early online and appearing in an upcoming issue of The Lancet shows that 2 different antimicrobial regimens for treating buruli ulcer (Mycobacterium ulcerans infection) are effective at treating early, limited disease. Surgery was the standard treatment for Buruli ulcer disease until the World Health Organization (WHO) issued provisional guidelines in 2004 recommending treatment with antimicrobial drugs (streptomycin and rifampicin) in addition to surgery. In the current study, Tjip S van der Werf, MD, University Medical Centre Groningen, Groningen, the Netherlands, and colleagues investigated the efficacy of 2 regimens of antimicrobial treatment in early-stage M ulcerans infection. The randomised trial was undertaken in 2 sites in Ghana. Patients were eligible for enrolment if they were aged 5 years or older and had early (duration <6 months), limited (cross-sectional diameter <10 cm), M ulcerans infection confirmed by dry-reagent-based PCR. Eligible patients were randomly assigned to receive intramuscular streptomycin 15 mg/kg once daily and oral rifampicin 10 mg/kg once daily for 8 weeks (8-week streptomycin group; n = 76) or streptomycin and rifampicin for 4 weeks followed by rifampicin and clarithromycin (7.5 mg/kg once daily), both orally, for 4 weeks (4-week streptomycin plus 4-week clarithromycin group; n = 75). The primary endpoint was lesion healing at 1 year after the start of treatment without lesion recurrence or extensive surgery. The researchers found that 96% of patients in the 8-week streptomycin group and 91% of patients in the 4-week streptomycin plus 4-week clarithromycin group had healed lesions at 1 year. No patients had lesion recurrence at 1 year. Three participants experienced giddiness/dizziness as a result of the injected streptomycin (8-week streptomycin, 1; 4-week streptomycin plus 4-week clarithromycin, 2). One participant developed an injection abscess and 2 participants developed an abscess close to the initial lesion, which was incised and drained (all 3 participants were in the 4-week streptomycin plus 4-week clarithromycin group). “Our study has shown that early, limited M ulcerans infection can be safely and effectively managed by antimicrobial treatment alone, without surgical debridement,” the authors wrote. “The drug regimen proposed by WHO, consisting of 8 weeks of streptomycin and rifampicin, seemed effective and was not associated with deterioration requiring subsequent surgical debridement.” “Antimycobacterial treatment for M ulcerans infection is effective in early, limited disease,” they concluded. “Four weeks of streptomycin and rifampicin followed by 4 weeks of rifampicin and clarithromycin has similar efficacy to 8 weeks of streptomycin and rifampicin; however, the number of injections of streptomycin can be reduced by switching to oral clarithromycin after 4 weeks.” In an accompanying comment Paul Johnson, MD, Infectious Diseases Department and Department of Medicine, Austin Health & University of Melbourne, and WHO Collaborating Centre for Mycobacterium ulcerans (Western Pacific Region), Melbourne, VIC, Australia said: “Nienhuis and colleagues have established beyond reasonable doubt that early and limited Buruli can be effectively treated with antibiotics, without surgery. In so doing they have extended the excellent work of WHO, Etuaful and colleagues, and Chauty and co-workers, and established a benchmark for subsequent trials that could assess new antibiotic combinations. Skilled surgery and good rehabilitation will still be needed for some cases of Buruli disease, but the question of whether there a role for antibiotics in the treatment of Buruli ulcer has now been answered with a resounding yes.” SOURCE: The Lancet E-mail this page to a friend or colleague! To print, use this version