Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Feasibility of the patch
研究概览
简要总结
This study aims at evaluating the diagnosis performances of the LTS-2 DEC patch for onchocerciasis compared to the gold standard which are the skin snips. This study will be conducted in Cameroon in two different areas : Ngog-Mapubi and Bafia Health Districts (one area only endemic for onchocerciasis, and one area endemic for both loiasis and onchocerciasis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Results from LTS-2 patch will be immediately known by both participant and investigators ; but results from skin snips will be masked both for participant and investigators.
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
- 是
入选标准
- •All voluntary adults
排除标准
- •General acute infection (temperature ≥ 38,5°C)
- •Impaired general condition
- •Ivermectin taken in the 6 last months
- •Known allergies to one of the component of the patch
- •Dermatological acute infection (bacterial, atopic, prurigo, or zona)
结局指标
主要结局
Feasibility of the patch
时间窗: 24 hours
Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
Tolerability of the patch
时间窗: 24 hours
Proportion of individuals having developed a generalized Mazzotti's reaction
次要结局
- Diagnosis performances(24 hours)
- Loiasis and cross-reactivity assessment(24 hours)
- Semi-quantitative scoring of the LTS-2 DEC patch results(24 hours)