High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Hospital Universitário Professor Edgard Santos

Status and phase: Terminated; Phase 3

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Meglumine Antimoniate; Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01953744

FlucoLBrBaMa

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Fluconazole

Experimental group

Description:

Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.

Treatment:

Drug: Fluconazole

Meglumine Antimoniate

Active Comparator group

Description:

Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.

Treatment:

Drug: Meglumine Antimoniate