Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 3
- 主要终点
- Positive result for this test
研究概览
简要总结
The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a composite reference standard test (Direct examination of skin smears + PCR test) in patients with clinically suspected Cutaneous Leishmaniasis disease in Morocco.
详细描述
Study participants are recruited in nine health centers located in fourthree CL endemic provinces. The RDT under evaluation (index test) is the CL Detect™ Rapid Test (InBios, USA); a membrane-based amastigote antigen (peroxidoxin) detection test. The reference standard consists of two tests: direct examination of skin smears and PCR. For each patient, the health professional takes one dental broach sample and four skin smear samples from a single lesion. The dental broach sample is used for the RDT, which is done once. The skin smear samples are sent to provincial laboratories for microscopy testing and to reference laboratories in Morocco and Belgium for PCR testing by ITS1 PCR, Hsp70 genotyping and parasite load determination. Readers of index and reference tests do not have access to clinical information or any other test results. The results of the test under evaluation (RDT) and the molecular tests (PCR) are not communicated to the patient or her/his physician, as case management has to follow current clinical guidelines.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with suspected Cutaneous Leishmaniasis wound(s) in apparently healthy state
- •Who is able to learn the Information sheet and sign the Informed consent form by them selves or by their parents with the presence or not of a witness (for illiterate people)
- •Who satisfy the following criteria :
- •with an ulcerative lesion in any accessible part of the body to perform the dental broach and the scraping.
- •Just one ulcerative lesion by patient could be selected (The newest and the less infected)
- •Lesion should be less than 04 months of age
排除标准
- •Patients with only nodular, papular, macular or nodulo-papular suspected CL forms
- •Patients with ulcerative lesions with a suspected bacteria origin which could disappear after a short course of antibiotic treatment.
- •Patients who already received during the last two months, prior to signing the consent, a physical treatment (e.g. cryotherapy, thermotherapy, Laser) or a traditional treatment (e.g. burn, acide, traditional scraping)
- •Patients presenting other disease with the need to take anti-parasite treatments
- •Patient with a acute or chronic disease needing hospitalization
- •Patient who already received antimoniate treatment incomplete or complete duration and dose against CL
- •Any situation that could engage the security of the patient or of the health professional (e.g. People with a psychiatric trouble or a mental handicap )
- •For children less than 12 years old, the decision of participation is mainly based on the condition that their parents are able to learn and understand the information sheet and sign the informed consent form
结局指标
主要结局
Positive result for this test
时间窗: 50 minutes
次要结局
未报告次要终点
研究者
Issam Bennis, MD
Doctor
National School of Public Health, Morocco