Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Lesion size
研究概览
简要总结
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
详细描述
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •one ulcerative lesion ≤ 900 mm2 in total area,
- •≥ 12 years,
- •parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
- •no antileishmanial therapy in the last 3 months,
- •no mucosal lesions,
- •no history of significant concomitant diseases including immunosuppression.
排除标准
- 未提供
研究组 & 干预措施
Intervention
miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
干预措施: miltefosine plus intralesional pentamidine (Drug)
结局指标
主要结局
Lesion size
时间窗: 6 months post therapy
area of lesion
次要结局
- systemic adverse effects(days 1 to 28 of therapy)
- adverse effects at site(days 1, 3, 5 of therapy)