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

Launched by DRUGS FOR NEGLECTED DISEASES · Apr 29, 2015

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Eligibility criteria

• 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