High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis

The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.

Inclusion Criteria:

• Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
• Number of lesions: 1 to 3 ulcerative lesions.
• Lesion´s diameter: 1 to 5 cm.
• Disease duration: up to three months.

Exclusion Criteria:

• 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/biopsy/PCR)or negative Montenegro test

• Any history of prior anti-leishmania therapy

• Any condition which compromises ability to comply with the study procedures

  • Administrative reasons:

• Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)

• Anticipated non-availability for study visits/procedures