Documenting Clinical Outcomes of Patients Receiving Miltefosine for the Treatment of Complicated Cutaneous Leishmaniasis in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Assess final treatment response
研究概览
简要总结
Cutaneous Leishmaniasis in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are cLCL, MCL, and DCL. National guidelines recommend equally all drugs that are also used for VL treatment. Miltefosine is one of these recommended medications but remains underused due to scarcity of drugs.
Outcomes of patients receiving miltefosine have never been documented systematically in Ethiopia until today. This is needed to provide evidence to advocate for increased access to miltefosine in Ethiopia, and to establish baseline data for future research on CL treatment options. The aim of this study is to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using miltefosine within a routine care setting located in an endemic area in Ethiopia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parasitologically or clinically confirmed diagnosis of Leishmaniasis
- •Clinical routine care decision to initiate miltefosine
排除标准
- •Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable
研究组 & 干预措施
Complicated CL in Gondar
Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment
干预措施: Miltefosine (administration is not part of study procedures) (Drug)
Complicated CL in Boru Meda
Patients treated with miltefosine in Boru Meda hospital will be followed up to see outcomes of treatment
干预措施: Miltefosine (administration is not part of study procedures) (Drug)
结局指标
主要结局
Assess final treatment response
时间窗: Day 90
proportion of index lesions with cure, good, partial and no treatment response
次要结局
- Early and late treatment response(Day 28, Day 180)
- Adherence(Day 28)
- Treatment failure(Day 90, Day 180)
- Predictors of cure(Day 90)