Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Cure rate or complete cicatrization of the ulcer.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fluconazole
Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
Intervention: Fluconazole (Drug)
Meglumine Antimoniate
Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.
Intervention: Meglumine Antimoniate (Drug)
Outcomes
Primary Outcomes
Cure rate or complete cicatrization of the ulcer.
Time Frame: 6 months
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.
Secondary Outcomes
- Initial cure rate or complete cicatrization of the ulcer(2 months)
Investigators
Paulo Roberto Lima Machado
Associate Researcher
Hospital Universitário Professor Edgard Santos