OBJECTIVE: Buruli ulcer disease (BU), caused by Mycobacterium ulcerans, is endemic in many regions of Africa and causes substantial physical disability. Surgical resection, currently the mainstay of clinical management of BU, is impractical in many endemic areas. Therefore, the study was undertaken to evaluate an antibiotic regimen for medical management of BU. METHODS: A randomized, placebo-controlled pilot study of dapsone plus rifampin versus placebo was conducted. RESULTS:Forty-one participants were recruited in a BU-endemic zone of Côte d'Ivoire. Thirty persons completed the 2-month trial: 15 were treated withplacebo and 15 with dapsone and rifampin. On blinded evaluation of photographs of the ulcers, clinicians with experience examining BU judged that 82% of ulcers in the treatment group improved compared with 75% in the placebo group (P=0.51). The median change in ulcer size was a decrease of 14.0 cm2 in the treatment group and a decrease of 2.5 cm2 in the placebo group (P=0.02), but initial ulcer sizes were larger in the treatment group (median 26.2 cm2) compared with the placebo group (median 4.8 cm2) (P=0.04). CONCLUSIONS: Results of this study indicate that larger studies of antimycobacterial therapy of BU are warranted and can be successfully undertaken.
RCT Entities:
OBJECTIVE:Buruli ulcer disease (BU), caused by Mycobacterium ulcerans, is endemic in many regions of Africa and causes substantial physical disability. Surgical resection, currently the mainstay of clinical management of BU, is impractical in many endemic areas. Therefore, the study was undertaken to evaluate an antibiotic regimen for medical management of BU. METHODS: A randomized, placebo-controlled pilot study of dapsone plus rifampin versus placebo was conducted. RESULTS: Forty-one participants were recruited in a BU-endemic zone of Côte d'Ivoire. Thirty persons completed the 2-month trial: 15 were treated with placebo and 15 with dapsone and rifampin. On blinded evaluation of photographs of the ulcers, clinicians with experience examining BU judged that 82% of ulcers in the treatment group improved compared with 75% in the placebo group (P=0.51). The median change in ulcer size was a decrease of 14.0 cm2 in the treatment group and a decrease of 2.5 cm2 in the placebo group (P=0.02), but initial ulcer sizes were larger in the treatment group (median 26.2 cm2) compared with the placebo group (median 4.8 cm2) (P=0.04). CONCLUSIONS: Results of this study indicate that larger studies of antimycobacterial therapy of BU are warranted and can be successfully undertaken.
Authors: S Etuaful; B Carbonnelle; J Grosset; S Lucas; C Horsfield; R Phillips; M Evans; D Ofori-Adjei; E Klustse; J Owusu-Boateng; G K Amedofu; P Awuah; E Ampadu; G Amofah; K Asiedu; M Wansbrough-Jones Journal: Antimicrob Agents Chemother Date: 2005-08 Impact factor: 5.191
Authors: Claire L Gordon; John A Buntine; John A Hayman; Caroline J Lavender; Janet A M Fyfe; Patrick Hosking; Mike Starr; Paul D R Johnson Journal: PLoS Negl Trop Dis Date: 2010-11-30