{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T07:43:46Z","timestamp":1772005426876,"version":"3.50.1"},"reference-count":10,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2011,7,1]]},"abstract":"<jats:p>Miltefosine (target dose of 2.5 mg\/kg\/day for 28 days) is the recommended treatment for visceral leishmaniasis (kala-azar) in Bangladesh on the basis of data from India. We evaluated miltefosine in a phase IV trial of 977 patients in Bangladesh. At the six-month final follow up, 701 were cured. 24 showed initial treatment failure, and 95 showed treatment failure at 6 months, although 73 of the 95 showed treatment failure solely by the criterion of low hemoglobin values. One hundred twenty-one patients were not assessable. With the conservative assumption that all low hemoglobin values represented treatment failure, the final per protocol cure rate was 85%. Of 13 severe adverse events, 6 led to treatment discontinuation and 7 resulted in deaths, but only 1 death (associated with diarrhea) could be attributed to drug. Nearly all non-serious adverse events were gastrointestinal: vomiting in 25% of patients and diarrhea in 8% of patients. Oral miltefosine is an attractive alternative to intramuscular antimony and intravenous amphotericin B for treatment of kala-azar in Bangladesh.<\/jats:p>","DOI":"10.4269\/ajtmh.2011.10-0661","type":"journal-article","created":{"date-parts":[[2011,7,6]],"date-time":"2011-07-06T18:34:20Z","timestamp":1309977260000},"page":"66-69","source":"Crossref","is-referenced-by-count":53,"title":["Phase IV Trial of Miltefosine in Adults and Children for Treatment of Visceral Leishmaniasis (Kala-Azar) in Bangladesh"],"prefix":"10.4269","volume":"85","author":[{"given":"Mahmudur","family":"Rahman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Be-Nazir","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Abul","family":"Faiz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Zafor Ullah","family":"Chowdhury","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Quazi Tarikul","family":"Islam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahman","family":"Sayeedur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Ridwanur","family":"Rahman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moazzem","family":"Hossain","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdul Mannan","family":"Bangali","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ziauddin","family":"Ahmad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Nazrul","family":"Islam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. G. Nicholas","family":"Mascie-Taylor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Berman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Byron","family":"Arana","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"key":"R1","series-title":"Lancet Infect Dis","first-page":"494","article-title":"Visceral leishmaniasis: current status of control, diagnosis, and treatment, and proposed research and development agenda","volume":"2","author":"Guerin","year":"2002"},{"key":"R2","series-title":"Clin Infect Dis","first-page":"1104","article-title":"Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic","volume":"31","author":"Sundar","year":"2000"},{"key":"R3","series-title":"N Engl J Med","first-page":"504","article-title":"Single-dose liposomal amphotericin B for visceral leishmaniasis in India","volume":"362","author":"Sundar","year":"2010"},{"key":"R4","series-title":"PLoS Negl Trop Dis","first-page":"e818","article-title":"Cost-effectiveness analysis of combination therapies for visceral leishmaniasis in the Indian subcontinent","volume":"4","author":"Meheus","year":"2010"},{"key":"R5","series-title":"N Engl J Med","first-page":"1739","article-title":"Oral miltefosine for Indian visceral leishmaniasis","volume":"347","author":"Sundar","year":"2002"},{"key":"R6","series-title":"J Infect Dis","first-page":"591","article-title":"Phase 4 trial of miltefosine for the treatment of Indian visceral leishmaniasis","volume":"196","author":"Bhattacharya","year":"2007"},{"key":"R7","series-title":"Trans R Soc Trop Med Hyg","first-page":"32","article-title":"Diagnostic tests for kala-azar: a multi-centre study of the freeze-dried DAT, rK39 strip test and KAtex in east Africa and the Indian subcontinent","volume":"102","author":"Boelaert","year":"2008"},{"key":"R8","series-title":"Common Toxicity Criteria of the NCI","year":"1999"},{"key":"R9","series-title":"N Engl J Med","first-page":"1795","article-title":"Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis","volume":"341","author":"Jha","year":"1999"},{"key":"R10","series-title":"Clin Infect Dis","first-page":"556","article-title":"Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions","volume":"45","author":"Sundar","year":"2007"}],"container-title":["The American Society of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/85\/1\/article-p66.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/85\/1\/article-p66.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/85\/1\/article-p66.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,7]],"date-time":"2024-08-07T19:43:24Z","timestamp":1723059804000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/85\/1\/article-p66.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,7,1]]},"references-count":10,"journal-issue":{"issue":"1"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.2011.10-0661","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,7,1]]}}}