High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitário Professor Edgard Santos
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Federal University of Bahia
• Treatments: Fluconazole; Meglumine Antimoniate

Criteria

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