High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

NCT01953744 ↗

Phase 3 Terminated 53 enrolled Hospital Universitário Professor Edgard Santos Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab Federal University of Bahia · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.

Timeline

Start: 2014-02
Primary completion: 2015-04
Completion: 2015-11

Outcome

Missed primary endpoint

Stopped: “Low cure rate in the study (fluconazole) group”

paper 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sbv group (P = .04). PMID 27803094 ↗

paper 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 PMID 27803094 ↗

Publications

Prates FV, Dourado ME, Silva SC, Schriefer A, Guimaraes LH, Brito MD, Almeida J, Carvalho EM, Machado PR. Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial. Clin Infect Dis. 2017 Jan 1;64(1):67-71. doi: 10.1093/cid/ciw662. Epub 2016 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluconazole	Small molecule	6 mg/kg	Oral
Subject	Fluconazole	Small molecule	8 mg/kg	Oral
Comparator	Meglumine antimonate	Other / unclassified	20 mg/kg	Intravenous