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...

Celý popis

Uložené v:
Podrobná bibliografia
Vydané v:Clinical infectious diseases Ročník 64; číslo 1; s. 67
Hlavní autori: Prates, Fernanda V de O, Dourado, Mayra E F, Silva, Silvana C, Schriefer, Albert, Guimarães, Luiz H, Brito, Maria das Graças O, Almeida, Juliana, Carvalho, Edgar M, Machado, Paulo R L
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States 01.01.2017
Predmet:
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
fluconazole
cutaneous leishmaniasis
pentavalent antimony
Leishmania (V.) braziliensis
ISSN:1537-6591, 1537-6591
On-line prístup:Zistit podrobnosti o prístupe
Tagy: Pridať tag
Žiadne tagy, Buďte prvý, kto otaguje tento záznam!
Popis
Shrnutí: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.
Bibliografia:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ObjectType-Undefined-3
ISSN:1537-6591
1537-6591
DOI:10.1093/cid/ciw662