{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:49:40Z","timestamp":1792799380510,"version":"4.5.0"},"reference-count":19,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2011,2,4]]},"abstract":"<jats:p>Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in <jats:italic>Leishmania<\/jats:italic> (<jats:italic>Viannia<\/jats:italic>) <jats:italic>guyanensis<\/jats:italic>. In this phase II\/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg\/kg\/day\/28 days) (<jats:italic>N<\/jats:italic> = 60) or parenteral antimony (15\u201320 mg\/Sb\/kg\/day\/20 days) (<jats:italic>N<\/jats:italic> = 30) according to age groups: 2\u201312 y\/o and 13\u201365 y\/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8\u201382.7) and 53.6% (95% CI = 33.9\u201372.5) (<jats:italic>P<\/jats:italic> = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.<\/jats:p>","DOI":"10.4269\/ajtmh.2011.10-0155","type":"journal-article","created":{"date-parts":[[2011,2,3]],"date-time":"2011-02-03T17:02:07Z","timestamp":1296752527000},"page":"255-260","source":"Crossref","is-referenced-by-count":135,"title":["Randomized Controlled Clinical Trial to Access Efficacy and Safety of Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil"],"prefix":"10.4269","volume":"84","author":[{"given":"Anette","family":"Chrusciak-Talhari","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reynaldo","family":"Dietze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Chrusciak Talhari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto Moreira","family":"da Silva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen Priscila","family":"Gadelha Yamashita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerson","family":"de Oliveira Penna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulo Roberto","family":"Lima Machado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sin\u00e9sio","family":"Talhari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"R1","series-title":"Am J Trop Med Hyg","first-page":"645","article-title":"Characterization and classification of leishmanial parasites from humans, wild mammals, and sand flies in the Amazon region of Brazil","volume":"44","author":"Grimaldi","year":"1991"},{"key":"R2","series-title":"Mem Inst Oswaldo Cruz","first-page":"435","article-title":"The dermal leishmaniases of Brazil, with special reference to the ecoepidemiology of the disease in Amazonia","volume":"89","author":"Lainson","year":"1994"},{"key":"R3","series-title":"Manual de Vigil\u00e2ncia da Leishmaniose Tegumentar Americana","author":"Minist\u00e9rio","year":"2007"},{"issue":"(Suppl 1)","key":"R4","series-title":"Trans R Soc Trop Med Hyg","first-page":"S26","article-title":"Oral miltefosine for the treatment of Indian visceral leishmaniasis","volume":"100","author":"Sundar","year":"2006"},{"issue":"(Suppl 1)","key":"R5","series-title":"Trans R Soc Trop Med Hyg","first-page":"S34","article-title":"Treatment of New World cutaneous leishmaniasis with miltefosine","volume":"100","author":"Soto","year":"2006"},{"key":"R6","series-title":"Clin Infect Dis","first-page":"57","article-title":"Treatment of American cutaneous leishmaniasis with miltefosine, an oral agent","volume":"33","author":"Soto","year":"2001"},{"key":"R7","series-title":"Clin Infect Dis","first-page":"1266","article-title":"Miltefosine for new world cutaneous leishmaniasis","volume":"38","author":"Soto","year":"2004"},{"key":"R8","series-title":"Clin Infec Dis","first-page":"350","article-title":"Treatment of Bolivian mucosal leishmaniasis with miltefosine","volume":"44","author":"Soto","year":"2007"},{"key":"R9","series-title":"Am J Trop Med Hyg","first-page":"210","article-title":"Efficacy of miltefosine for Bolivian cutaneous leishmaniasis","volume":"78","author":"Soto","year":"2008"},{"key":"R10","series-title":"J Infect Dis","first-page":"1846","article-title":"Influence of Leishmania (Viannia) species on the response to antimonial treatment in patients with American tegumentary leishmaniasis","volume":"195","author":"Arevalo","year":"2007"},{"key":"R11","series-title":"Clin Infect Dis","first-page":"223","article-title":"Clinical and parasite species risk factors for pentavalent antimonial treatment failure in cutaneous leishmaniasis in Peru","volume":"46","author":"Llanos-Cuentas","year":"2008"},{"key":"R12","series-title":"Rev Soc Bras Med Trop","first-page":"383","article-title":"Comparative study between sodium stibogluconate BP 88 and meglumina antimoniate for cutaneous leishmaniasis treatment: I. 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