Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Phase 2 Completed 180 enrolled Hospital Universitário Professor Edgard Santos AEterna Zentaris · collab Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab Ministerio de Ciencia e Innovación, Spain · collab Ministry of Health, Brazil · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

Timeline

Start: 2007-07
Primary completion: 2009-03
Completion: 2009-07

Outcome

Met primary endpoint

paper the definitive cure rate was 53.3% in the Sb(v) group and 75% in the miltefosine group (difference of 21.7%, 95% CI 0.08% to 42.7%, p = 0.04). PMID 21200420 ↗

Publications

Machado PR, Ampuero J, Guimaraes LH, Villasboas L, Rocha AT, Schriefer A, Sousa RS, Talhari A, Penna G, Carvalho EM. Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. PLoS Negl Trop Dis. 2010 Dec 21;4(12):e912. doi: 10.1371/journal.pntd.0000912.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Meglumine antimonate	Other / unclassified	20 mg/kg	Intravenous
Subject	Miltefosine	Small molecule	2.5 mg/kg	Oral