Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States
概览
- 阶段
- 不适用
- 干预措施
- Skin Ulcers
- 疾病 / 适应症
- Skin Diseases
- 发起方
- U.S. Army Medical Research and Development Command
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- True Positive
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample.
详细描述
Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.
研究者
入排标准
入选标准
- •At least 18 years of age
- •Subject is able to give written informed consent
- •Subject has a skin ulcer that satisfies the following criteria for an index lesion:
- •less than 4 months in age
- •primarily ulcerative, not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
- •in a location suitable for collecting samples by dental broach and scraping
- •In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
排除标准
- •Received treatment for leishmaniasis or any treatment to the lesion even if not previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod, thermotherapy, photodynamic therapy, within 2 months prior to signing the consent form, with the exception of mercurochrome
研究组 & 干预措施
Skin Ulcers
Skin ulcers. No intervention. Subjects will be followed up by their respective primary providers.
结局指标
主要结局
True Positive
时间窗: within 1 hour after samples are taken
Positive by both the CL Detect™ Rapid Test and microscopy of an index lesion smear for amastigotes.
False Positive
时间窗: within 1 hour after samples are taken
Positive by the CL Detect™ Rapid Test but negative for Microscopy
True Negative
时间窗: within 1 hour after samples are taken
Negative by both the CL Detect™ Rapid Test device and Microscopy
False Negative
时间窗: within 1 hour after samples are taken
Negative by the CL Detect™ Rapid Test but positive for Microscopy
Specificity
时间窗: within 1 hour after samples are taken
Negative Specificity was calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives.
False Positive Rate
时间窗: within 1 hour after samples are taken
False positive rate (type 1 error, calculated as 1-specificity)