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

• Published in: Clinical infectious diseases Vol. 64; no. 1; pp. 67 - 71
• Main Authors: de O. Prates, Fernanda V., Dourado, Mayra E. F., Silva, Silvana C., Schriefer, Albert, Guimarães, Luiz H., das Graças O. Brito, Maria, Almeida, Juliana, Carvalho, Edgar M., Machado, Paulo R. L.
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 01.01.2017
• Subjects: Adolescent; Adult; Antimony - administration & dosage; Antimony - adverse effects; Antimony - therapeutic use; Antiprotozoal Agents - administration & dosage; Antiprotozoal Agents - adverse effects; Antiprotozoal Agents - therapeutic use; ARTICLES AND COMMENTARIES; Brazil; Clinical trials; Drug dosages; Female; Fluconazole - administration & dosage; Fluconazole - adverse effects; Fluconazole - therapeutic use; Humans; Leishmania braziliensis; Leishmania braziliensis - drug effects; Leishmania braziliensis - genetics; Leishmaniasis, Cutaneous - diagnosis; Leishmaniasis, Cutaneous - drug therapy; Leishmaniasis, Cutaneous - parasitology; Male; Medical treatment; Middle Aged; Parasitic diseases; Parasitic protozoa; Pharmaceuticals; Side effects; Treatment Outcome; Young Adult; Bahia Brazil; ASW, Brazil; fluconazole; cutaneous leishmaniasis; pentavalent antimony; Leishmania (V.) braziliensis
• ISSN: 1058-4838; 1537-6591; 1537-6591
• DOI: 10.1093/cid/ciw662

Background. The treatment of cutaneous leishmaniasis (CL) caused by leishmania braziliensis in Brazil with pentavalent antimony (Sb) is associated with a high rate of failure, up to 45% of cases. In addition, Sb 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 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, 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 group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any replaces. The frequencies of adverse effects in the Sb 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. braziliensis. Clinical Trials Registration. NCT01953744.