This multicenter clinical trial will be conducted in Colombia, under the Centra Internacional de Entrenamiento en Investigaciones Medicas (CIDEIM) coordination in collaboration with Lyda Osorio, MD, PhD as Project 1 of the ICIDR program. This study will compare the efficacy and tolerability of the new oral drug, miltefosine with the standard drug therapy, Glucantime in children with cutaneous leishmaniasis (CL) caused by Leishmania of the Viannia subgenus. Pentavalent antimonials have been the standard treatment for CL for more than 50 years in spite of its parenteral use, high toxicity and relative high costs. On the other hand, children constitute a highly vulnerable population since more than 23% of the cases in the major Colombian endemic regions are patients under 12 years of age. Children also have a lower response to antimonial treatment explained by the different pharmacokinetic behaviour in these ages, where approximately half of the exposure to the drug is observed as a result of having twice the clearance rate as compared to adults. These data, along with the different immune response, make children bellow 12 years a population at high risk of treatment failure, increased morbidity, aesthetically deleterious scars or mucosal involvement. 120 children below 12 years will be enrolled. Half of the randomized patients will receive Glucantime 20mg/kg/day for 20 days (standard treatment), and the other half will receive miltefosine 2.5mg/kg/day for 28 days. A 60% efficacy of antimonials and 90% efficacy of miltefosine is expected. Clinical response will be assessed at the end of the treatment, and at 13 and 26 weeks. Also the presence of adverse events will be identified by clinical and laboratory examination. Ethical approval from the Institutional Review Boards at CIDEIM and other participation institutions will be obtained. The availability of an efficacious, tolerable, orally administrable treatment for dermal leishmaniasis would revolutionize the treatment and perhaps even the prevention of this disease.
Showing the most recent 10 out of 23 publications
