Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial.
BACKGROUND
The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sbv) is associated with a high rate of failure, up to 45% of cases. In addition, Sbvcan 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 Sbvprotocol (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 Sbv, 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 Sbvgroup (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 Sbvand 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.
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.
Fernanda V de O
FV
Prates
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.
Mayra E F
ME
Dourado
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.
Silvana C
SC
Silva
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.|Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais.
Albert
A
Schriefer
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.|Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais.
Luiz H
LH
Guimarães
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.
Maria das Graças O
MD
Brito
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.
Juliana
J
Almeida
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.|Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais.|Centro de Pesquisa Gonçalo Moniz, Fiocruz, Salvador, Bahia, Brazil.
Edgar M
EM
Carvalho
Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia.|Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais.
Paulo R L
PR
Machado
D000293:Adolescent; D000328:Adult; D000965:Antimony / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007892:Leishmania braziliensis / Q000187:drug effects* / Q000235:genetics; D016773:Leishmaniasis, Cutaneous / Q000175:diagnosis / Q000188:drug therapy* / Q000469:parasitology*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000981:Antiprotozoal Agents; D015725:Fluconazole; D000965:Antimony
Leishmania (V.) braziliensis; cutaneous leishmaniasis; fluconazole; pentavalent antimony