Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Inclusion criteria

• Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
• Number of lesions: 1 to 5 ulcerative lesions.
• Lesion´s diameter: 1 to 5 cm.
• Disease duration: up to three months.

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