Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial

Abstract

Background: The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb^v) is associated with a high rate of failure, up to 45% of cases. In addition, Sb^v can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required.

Methods: A randomized controlled clinical trial was conducted to compare the efficacy and safety of high-dosage oral fluconazole (6.5-8.0 mg/kg/d for 28 days) versus a standard Sb^v protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil.

Results: A total of 53 subjects were included in the trial; 26 were treated with Sb^v, and 27 with fluconazole. Intention-to-treat analysis showed initial cure rates (2 months after treatment) of 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sb^v group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any relapses. The frequencies of adverse effects in the Sb^v and fluconazole groups were similar, 34.6% versus 37% respectively. One patient treated with fluconazole discontinued treatment owing to malaise, headache, and moderate dizziness (Common Terminology Criteria for Adverse Events grade 2).

Conclusions: Oral fluconazole at a dosage of 6.5-8 mg/kg/d for 28 days should not be considered an effective treatment for CL caused by L. braziliensisClinical Trials Registration. NCT01953744.

Keywords: Leishmania (V.) braziliensis; cutaneous leishmaniasis; fluconazole; pentavalent antimony.