A pilot study of treatment of Buruli ulcer with rifampin and dapsone.
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.
Espey
David K
DK
International Health Program Office, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Djomand
Gaston
G
Diomande
Idrissa
I
Dosso
Mireille
M
Saki
Mathieu Z
MZ
Kanga
Jean-Marie
JM
Spiegel
Richard A
RA
Marston
Barbara J
BJ
Gorelkin
Leo
L
Meyers
Wayne M
WM
Portaels
Françoise
F
Deming
Michael S
MS
Horsburgh
C Robert
CR
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003622:Dapsone / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009165:Mycobacterium Infections, Nontuberculous / Q000188:drug therapy* / Q000382:microbiology; D019911:Mycobacterium ulcerans / Q000187:drug effects*; D010865:Pilot Projects; D012293:Rifampin / Q000627:therapeutic use*; D012883:Skin Ulcer / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D003622:Dapsone; D012293:Rifampin