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

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