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Clinical Trial
. 2011 Jul;85(1):66-9.
doi: 10.4269/ajtmh.2011.10-0661.

Phase IV trial of miltefosine in adults and children for treatment of visceral leishmaniasis (kala-azar) in Bangladesh

Mahmudur Rahman  1 , Be-Nazir Ahmed, M Abul Faiz, M Zafor Ullah Chowdhury, Quazi Tarikul Islam, Rahman Sayeedur, M Ridwanur Rahman, Moazzem Hossain, Abdul Mannan Bangali, Ziauddin Ahmad, M Nazrul Islam, C G Nicholas Mascie-Taylor, Jonathan Berman, Byron Arana
Affiliations
Clinical Trial

Phase IV trial of miltefosine in adults and children for treatment of visceral leishmaniasis (kala-azar) in Bangladesh

Mahmudur Rahman et al. Am J Trop Med Hyg. 2011 Jul.

Abstract

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.

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