Back to Search
Start Over
Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial.
- Source :
-
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2017 Jan 01; Vol. 64 (1), pp. 67-71. Date of Electronic Publication: 2016 Nov 01. - Publication Year :
- 2017
-
Abstract
- Background: The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb <superscript>v</superscript> ) is associated with a high rate of failure, up to 45% of cases. In addition, Sb <superscript>v</superscript> can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required.<br />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 <superscript>v</superscript> protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil.<br />Results: A total of 53 subjects were included in the trial; 26 were treated with Sb <superscript>v</superscript> , 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 <superscript>v</superscript> 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 <superscript>v</superscript> 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).<br />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.<br /> (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.)
- Subjects :
- Adolescent
Adult
Antimony administration & dosage
Antimony adverse effects
Antimony therapeutic use
Antiprotozoal Agents administration & dosage
Antiprotozoal Agents adverse effects
Brazil
Female
Fluconazole administration & dosage
Fluconazole adverse effects
Humans
Leishmania braziliensis genetics
Leishmaniasis, Cutaneous diagnosis
Male
Middle Aged
Treatment Outcome
Young Adult
Antiprotozoal Agents therapeutic use
Fluconazole therapeutic use
Leishmania braziliensis drug effects
Leishmaniasis, Cutaneous drug therapy
Leishmaniasis, Cutaneous parasitology
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6591
- Volume :
- 64
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
- Publication Type :
- Academic Journal
- Accession number :
- 27803094
- Full Text :
- https://doi.org/10.1093/cid/ciw662