Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity of CL detect Rapid Test using skin slit sampling
研究概览
简要总结
The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.
详细描述
Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.
The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Clinical suspicion of CL
排除标准
- •≤ 2 years of age
- •Not willing or able to provide consent/assent
- •CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
- •Co-morbidity with visceral leishmaniasis
- •On CL treatment at time of enrollment
结局指标
主要结局
Sensitivity, specificity of CL detect Rapid Test using skin slit sampling
时间窗: February 2019
% test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)
次要结局
- Species identification(February 2019)
- Sensitivity, specificity of CL detect Rapid Test compared to routine(February 2019)
- Sensitivity, specificity of routine testing(February 2019)
- Sensitivity, specificity of CL detect Rapid Test using dental broach sampling(February 2019)
- Sensitivity, specificity of tape disc sampling(February 2019)
- Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling(May 2018)
- Sensitivity, specificity of dental broach sample compared to skin slit sample(February 2019)
- Immunomodulatory mediators in CL lesions using non-invasive sampling(February 2019)