Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

Miltefosine efficacy will be >85%

Inclusion Criteria:

• 12 years or older
• nodules and papules consistent with post kala-azar dermal leishmaniasis
• parasitological confirmation of Leishmania infection

Exclusion Criteria:

• platelet count <100x 109/l,
• leukocyte count <2.5 x 109/l ,
• hemoglobin < 8.0 g/100 ml ,
• liver function tests >3 times upper limit of normal range,
• bilirubin >2 times upper limit of normal range,
• serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range);
• any non-compensated or uncontrolled condition,
• lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
• treatment with any anti-leishmanial drug within the previous 12 weeks.