Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Exclusion Criteria

• •Safety concerns:
• •Thrombocyte count \<30 x 109/l
• •Leukocyte count \<1 x 109/l
• •Hemoglobin \<5 g/100 ml
• •ASAT, ALAT, AP \>3 times upper limit of normal range
• •Bilirubin \>2 times upper limit of normal range
• •Serum creatinine or BUN \>1.5 times upper limit of normal range
• •Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
• •Immunodeficiency or antibody to HIV
• •Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
• •Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
• •Lack of suitability for the trial:
• •Negative parasitology (aspirate/smear)or negative Montenegro test
• •Any history of prior anti-leishmania therapy
• •Any condition which compromises ability to comply with the study procedures
• •Concomitant serious infection other than cutaneous
• •Administrative reasons:
• •Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
• •Anticipated non-availability for study visits/procedures