{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T01:10:21Z","timestamp":1792285821802,"version":"4.4.0"},"reference-count":50,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,6]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>\n                    New World Mucosal Leishmaniasis (ML) is predominantly caused by\n                    <jats:italic>Leishmania braziliensis.<\/jats:italic>\n                    We performed the first randomized trial of the three recommended agents for this disease\u2014intravenous pentavalent antimony (Sb), intravenous liposomal amphotericin B (LAMB), oral miltefosine\u2014with 24-month follow-up. Upon study enrollment, disease was scored by the number of sites (oro\u2013nasal\u2013palate, pharynx, larynx) and degree of disease at each site (maximum score = 60.) Our criterion for \u201ccure\u201d was \u226590% diminution in the enrollment score. Cure rates were 20\/40 (50%) for Sb, 18\/40 (45%) for LAMB, and 23\/40 (57%) for miltefosine. Cure was highly dependent on whether the patient was being treated for the first time (39\/55 = 71% cure) or undergoing repeat treatment (22\/63 = 35% cure). The primary reason for the low cure rate for repeat patients was laryngeal disease at enrollment. For all patients, na\u00efve patients, and repeat patients, the miltefosine cure rate was highest but not statistically so. A curative score at 2\u20136 months of follow-up had a predictive value of 94% for cure. It is notable that 14 of the 57 treatment failures (25%) were attributable to relapses occurring more than 24 months after therapy completion. Myalgias\/arthralgias\/general bodily discomfort occurred for LAMB and Sb patients; diarrhea and motion sickness occurred for miltefosine patients; Electrocardiogram abnormalities (occasionally severe) were seen in LAMB and Sb patients. When choosing a treatment of a ML patient, cure rates in part based on disease location and absence\/presence of previous treatment, route of administration, tolerability, and cost should be considered. Patients should be followed for \u22652 years.\n                  <\/jats:p>","DOI":"10.4269\/ajtmh.25-0619","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T15:11:39Z","timestamp":1773328299000},"page":"874-881","source":"Crossref","is-referenced-by-count":1,"title":["Treatment of New World Mucosal Leishmaniasis: Randomized Comparison of Glucantime\u00ae, Liposomal Amphotericin B, and Miltefosine"],"prefix":"10.4269","volume":"114","author":[{"given":"Jaime","family":"Soto","sequence":"first","affiliation":[{"name":"FUNDERMA (Fundaci\u00f3n Nacional de Dermatolog\u00eda), Santa Cruz, Bolivia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Soto","sequence":"additional","affiliation":[{"name":"FUNDERMA (Fundaci\u00f3n Nacional de Dermatolog\u00eda), Santa Cruz, Bolivia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Paz","sequence":"additional","affiliation":[{"name":"Hospital Dermatologico De Jorochito, Santa Cruz, Bolivia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Rivero","sequence":"additional","affiliation":[{"name":"Hospital Dermatologico De Jorochito, Santa Cruz, Bolivia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"S\u00e1nchez","sequence":"additional","affiliation":[{"name":"DermaL\u00e1ser, Santa Cruz, Bolivia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Arteaga","sequence":"additional","affiliation":[{"name":"Pr\u00e1ctica privada, Santa Cruz, Bolivia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Berman","sequence":"additional","affiliation":[{"name":"AB Foundation, North Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"b1","series-title":"Scand J Immunol","first-page":"70","article-title":"Mucosal leishmaniasis patients display an activated inflammatory T-cell phenotype associated with a nonbalanced monocyte population","volume":"63","author":"Gaze","year":"2006"},{"key":"b2","series-title":"Trans R Soc Trop Med Hyg","first-page":"221","article-title":"Spontaneous clinical resolution without specific treatment in mucosal leishmaniasis","volume":"85","author":"Marsden","year":"1991"},{"key":"b3","series-title":"Am J Trop Med Hyg","first-page":"24","article-title":"Diagnosis and treatment of leishmaniasis: Clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH)","volume":"96","author":"Aronson","year":"2017"},{"key":"b4","series-title":"PLoS One","first-page":"e35671","article-title":"Leishmaniasis worldwide and global estimates of its incidence","volume":"7","author":"Alvar","year":"2012"},{"key":"b5","series-title":"Am J Trop Med Hyg","first-page":"761","article-title":"Mucosal leishmaniasis: A retrospective study of 327 cases from an endemic area of Leishmania (Viannia) braziliensis.","volume":"97","author":"Cincura","year":"2017"},{"key":"b6","series-title":"Am J Trop Med Hyg","first-page":"1319","article-title":"Case report: Mucosal leishmaniasis in New York City","volume":"102","author":"Murray","year":"2020"},{"key":"b7","article-title":"Control of the Leishmaniases: WHO Technical Report Series No. 949.","year":"2010"},{"key":"b8","series-title":"Manual of Procedures for Leishmaniasis Surveillance and Control in the Region of the Americas","year":"2024"},{"key":"b9","series-title":"Am J Trop Med Hyg","first-page":"1214","article-title":"Efficacy and safety of liposomal amphotericin B for the treatment of mucosal leishmaniasis from the New World: A retrospective study","volume":"93","author":"Cunha","year":"2015"},{"key":"b10","series-title":"Am J Trop Med Hyg","first-page":"818","article-title":"Can we use a lower dose of liposomal amphotericin B for the treatment of mucosal American leishmaniasis?","volume":"85","author":"Amato","year":"2011"},{"key":"b11","series-title":"PLoS One","first-page":"e0218786","article-title":"Comparative study on liposomal amphotericin B and other therapies in the treatment of mucosal leishmaniasis: A 15-year retrospective cohort study","volume":"14","author":"Santos","year":"2019"},{"key":"b12","article-title":"Highlights of Prescribing Information.","year":"2021"},{"key":"b13","series-title":"Clin Infect Dis","first-page":"350","article-title":"Treatment of Bolivian mucosal leishmaniasis with miltefosine","volume":"44","author":"Soto","year":"2007"},{"key":"b14","series-title":"Am J Trop Med Hyg","first-page":"963","article-title":"Inhaled pentamidine for Bolivian mucosal leishmaniasis","volume":"112","author":"Soto","year":"2025"},{"key":"b15","series-title":"PLoS Negl Trop Dis","first-page":"e0010931","article-title":"The cure rate after different treatments for mucosal leishmaniasis in the Americas: A systematic review","volume":"16","author":"Carvalho","year":"2022"},{"key":"b16","series-title":"Rev Soc Bras Med Trop","first-page":"e20180292","article-title":"A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis","volume":"52","author":"Sampaio","year":"2019"},{"key":"b17","series-title":"Medicina (Buenos Aires)","first-page":"371","article-title":"Miltefosina versus antimoniatode meglumina en el tratamiento de la leishmaniasis mucosa","volume":"74","author":"Garc\u0131a Bustos","year":"2014"},{"key":"b18","series-title":"Am J Trop Med Hyg","first-page":"1182","article-title":"Treatment of Bolivian Leishmania braziliensis cutaneous and mucosal leishmaniasis","volume":"106","author":"Soto","year":"2022"},{"key":"b19","series-title":"Ann Intern Med","first-page":"934","article-title":"Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis","volume":"113","author":"Franke","year":"1990"},{"key":"b20","series-title":"Am J Trop Med Hyg","first-page":"266","article-title":"Treatment of mucosal leishmaniasis in Latin America: Systematic review","volume":"77","author":"Amato","year":"2007"},{"key":"b21","series-title":"J Eur Acad Dermatol Venereol","first-page":"1026","article-title":"Mucosal leishmaniasis: Description of case management approaches and analysis of risk factors for treatment failure in a cohort of 140 patients in Brazil","volume":"23","author":"Amato","year":"2009"},{"key":"b22","article-title":"AmBisome\u00ae (Amphotericin B) Liposome for Injection.","year":"2012"},{"key":"b23","article-title":"Amphotericin B Liposomal Prices, Coupons, Copay Cards & Patient Assistance.","year":"2025"},{"key":"b24","series-title":"Open Forum Infect Dis","first-page":"ofaf391","article-title":"Examining pricing and availability for neglected tropical disease therapies in the United States","volume":"12","author":"Goh","year":"2025"},{"key":"b25","series-title":"PLoS Negl Trop Dis","first-page":"e0009650","article-title":"Visceral Leishmaniasis in pregnancy and vertical transmission: A systematic literature review on the therapeutic orphans","volume":"15","author":"Dahal","year":"2021"},{"key":"b1","series-title":"Scand J Immunol","first-page":"70","article-title":"Mucosal leishmaniasis patients display an activated inflammatory T-cell phenotype associated with a nonbalanced monocyte population","volume":"63","author":"Gaze","year":"2006"},{"key":"b2","series-title":"Trans R Soc Trop Med Hyg","first-page":"221","article-title":"Spontaneous clinical resolution without specific treatment in mucosal leishmaniasis","volume":"85","author":"Marsden","year":"1991"},{"key":"b3","series-title":"Am J Trop Med Hyg","first-page":"24","article-title":"Diagnosis and treatment of leishmaniasis: Clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH)","volume":"96","author":"Aronson","year":"2017"},{"key":"b4","series-title":"PLoS One","first-page":"e35671","article-title":"Leishmaniasis worldwide and global estimates of its incidence","volume":"7","author":"Alvar","year":"2012"},{"key":"b5","series-title":"Am J Trop Med Hyg","first-page":"761","article-title":"Mucosal leishmaniasis: A retrospective study of 327 cases from an endemic area of Leishmania (Viannia) braziliensis.","volume":"97","author":"Cincura","year":"2017"},{"key":"b6","series-title":"Am J Trop Med Hyg","first-page":"1319","article-title":"Case report: Mucosal leishmaniasis in New York City","volume":"102","author":"Murray","year":"2020"},{"key":"b7","article-title":"Control of the Leishmaniases: WHO Technical Report Series No. 949.","year":"2010"},{"key":"b8","series-title":"Manual of Procedures for Leishmaniasis Surveillance and Control in the Region of the Americas","year":"2024"},{"key":"b9","series-title":"Am J Trop Med Hyg","first-page":"1214","article-title":"Efficacy and safety of liposomal amphotericin B for the treatment of mucosal leishmaniasis from the New World: A retrospective study","volume":"93","author":"Cunha","year":"2015"},{"key":"b10","series-title":"Am J Trop Med Hyg","first-page":"818","article-title":"Can we use a lower dose of liposomal amphotericin B for the treatment of mucosal American leishmaniasis?","volume":"85","author":"Amato","year":"2011"},{"key":"b11","series-title":"PLoS One","first-page":"e0218786","article-title":"Comparative study on liposomal amphotericin B and other therapies in the treatment of mucosal leishmaniasis: A 15-year retrospective cohort study","volume":"14","author":"Santos","year":"2019"},{"key":"b12","article-title":"Highlights of Prescribing Information.","year":"2021"},{"key":"b13","series-title":"Clin Infect Dis","first-page":"350","article-title":"Treatment of Bolivian mucosal leishmaniasis with miltefosine","volume":"44","author":"Soto","year":"2007"},{"key":"b14","series-title":"Am J Trop Med Hyg","first-page":"963","article-title":"Inhaled pentamidine for Bolivian mucosal leishmaniasis","volume":"112","author":"Soto","year":"2025"},{"key":"b15","series-title":"PLoS Negl Trop Dis","first-page":"e0010931","article-title":"The cure rate after different treatments for mucosal leishmaniasis in the Americas: A systematic review","volume":"16","author":"Carvalho","year":"2022"},{"key":"b16","series-title":"Rev Soc Bras Med Trop","first-page":"e20180292","article-title":"A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis","volume":"52","author":"Sampaio","year":"2019"},{"key":"b17","series-title":"Medicina (Buenos Aires)","first-page":"371","article-title":"Miltefosina versus antimoniatode meglumina en el tratamiento de la leishmaniasis mucosa","volume":"74","author":"Garc\u0131a Bustos","year":"2014"},{"key":"b18","series-title":"Am J Trop Med Hyg","first-page":"1182","article-title":"Treatment of Bolivian Leishmania braziliensis cutaneous and mucosal leishmaniasis","volume":"106","author":"Soto","year":"2022"},{"key":"b19","series-title":"Ann Intern Med","first-page":"934","article-title":"Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis","volume":"113","author":"Franke","year":"1990"},{"key":"b20","series-title":"Am J Trop Med Hyg","first-page":"266","article-title":"Treatment of mucosal leishmaniasis in Latin America: Systematic review","volume":"77","author":"Amato","year":"2007"},{"key":"b21","series-title":"J Eur Acad Dermatol Venereol","first-page":"1026","article-title":"Mucosal leishmaniasis: Description of case management approaches and analysis of risk factors for treatment failure in a cohort of 140 patients in Brazil","volume":"23","author":"Amato","year":"2009"},{"key":"b22","article-title":"AmBisome\u00ae (Amphotericin B) Liposome for Injection.","year":"2012"},{"key":"b23","article-title":"Amphotericin B Liposomal Prices, Coupons, Copay Cards & Patient Assistance.","year":"2025"},{"key":"b24","series-title":"Open Forum Infect Dis","first-page":"ofaf391","article-title":"Examining pricing and availability for neglected tropical disease therapies in the United States","volume":"12","author":"Goh","year":"2025"},{"key":"b25","series-title":"PLoS Negl Trop Dis","first-page":"e0009650","article-title":"Visceral Leishmaniasis in pregnancy and vertical transmission: A systematic literature review on the therapeutic orphans","volume":"15","author":"Dahal","year":"2021"}],"container-title":["The American Journal of Tropical Medicine and 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