Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Cure rate or complete cicatrization of the ulcer.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Fluconazole
Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
干预措施: Fluconazole (Drug)
Meglumine Antimoniate
Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.
干预措施: Meglumine Antimoniate (Drug)
结局指标
主要结局
Cure rate or complete cicatrization of the ulcer.
时间窗: 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.
次要结局
- Initial cure rate or complete cicatrization of the ulcer(2 months)
研究者
Paulo Roberto Lima Machado
Associate Researcher
Hospital Universitário Professor Edgard Santos