Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial
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 tre...
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| Vydáno v: | Clinical infectious diseases Ročník 64; číslo 1; s. 67 |
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| Hlavní autoři: | , , , , , , , , |
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| Jazyk: | angličtina |
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United States
01.01.2017
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| ISSN: | 1537-6591, 1537-6591 |
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| Abstract | 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.
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.
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 relapses. 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).
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. |
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| AbstractList | 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.
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.
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 relapses. 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).
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. 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, Sbv can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required.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, Sbv can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required. 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 Sbv protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil.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 Sbv protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil. 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 Sbv 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 Sbv 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).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 Sbv 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 Sbv 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). 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.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. |
| Author | Brito, Maria das Graças O Guimarães, Luiz H Almeida, Juliana Machado, Paulo R L Carvalho, Edgar M Silva, Silvana C Dourado, Mayra E F Schriefer, Albert Prates, Fernanda V de O |
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| Copyright | 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. |
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| Keywords | fluconazole cutaneous leishmaniasis pentavalent antimony Leishmania (V.) braziliensis |
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| Snippet | The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb
) is associated with a high rate of... The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sbv) is associated with a high rate of... |
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| SubjectTerms | Adolescent Adult Antimony - administration & dosage Antimony - adverse effects Antimony - therapeutic use Antiprotozoal Agents - administration & dosage Antiprotozoal Agents - adverse effects Antiprotozoal Agents - therapeutic use Brazil Female Fluconazole - administration & dosage Fluconazole - adverse effects Fluconazole - therapeutic use Humans Leishmania braziliensis - drug effects Leishmania braziliensis - genetics Leishmaniasis, Cutaneous - diagnosis Leishmaniasis, Cutaneous - drug therapy Leishmaniasis, Cutaneous - parasitology Male Middle Aged Treatment Outcome Young Adult |
| Title | Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial |
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