Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa

Inclusion Criteria: * Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis * Patients aged \> 4 to \< 12 years who are able to comply with the study protocol. * Patients for whom written informed consent has been signed by parents(s) or legal guardian * Weight \< 30 kg Exclusion Criteria: * Patients who are relapse cases * Patients who have received any anti-leishmanial drugs in the last 6 months * Patients with severe malnutrition (for children aged \<5 years, weight-for-height WHO reference curves by gender, z score \<-3; for children 5-12 years, BMI-for-age WHO reference curves for gender, z score \< -3) * Patients with positive HIV diagnosis * Patients with previous history of hypersensitivity reaction to miltefosine * Patients suffering from a concomitant severe infection such as Tuberculosis (TB) or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication * Patients suffering from other conditions associated with splenomegaly such as schistosomiasis * Pregnant or lactating women or female patient in childbearing age (reached menarche) * Patients with haemoglobin \< 5g/dl * Patients with White Blood Cells (WBC) \< 1 x 10³/mm³ * Patients with platelets \< 40,000/mm³ * Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range. * Patients with bilirubin more than 1.5 times the upper normal range * Patients with serum creatinine above the upper limit of normal (ULN) for age and gender. * Patients with clinical signs of severe VL disease such as jaundice and bleeding * Patients who cannot comply with the planned scheduled visits and procedures of the study protocol