High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Study Overview
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Brief Summary
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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.

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

Conditions
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Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Fluconazole
* Drug: Meglumine Antimoniate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluconazole<br>Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days. | Drug: Fluconazole<br>* Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.<br>|
| Active Comparator: Meglumine Antimoniate<br>Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days. | Drug: Meglumine Antimoniate<br>* Meglumine Antimoniate will be administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.<br>* Other names: Glucantime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate or complete cicatrization of the ulcer. | All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial cure rate or complete cicatrization of the ulcer | All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluconazole; Meglumine antimoniate;L.Braziliensis;, L.Guyanensis