Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- The sensitivity and specificity of UCP-CAA
研究概览
简要总结
Schistosomiasis is increasingly encountered among travellers returning from the tropics and is known for its focal endemicity, associated with the presence of the snail intermediate host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic due to the low intensity of infection, many infections likely go undiagnosed and will develop into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of schistosomiasis relies on egg detection, which has a poor sensitivity in low burden infections, or serology, which is inadequate to monitor cure. The department of parasitology of the Leiden University Medical Center has developed a novel diagnostic test based on the up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test can be performed on serum and urine to detect low intensity schistosomiasis infections and confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA in travellers with high-risk water contact.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any self-reported high risk water contact, including wading, showering, surfing, walking along wet shore bare-footed or washing with water from a high-risk source, within 12 weeks prior to reporting to the outpatient department
- •Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection
- •Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures
- •Able to provide informed consent
排除标准
- •Previous treatment for schistosomiasis
- •Known positive schistosomiasis serology
- •The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
结局指标
主要结局
The sensitivity and specificity of UCP-CAA
时间窗: 12 weeks after last water contact
The diagnostic performance of UCP-CAA will be assessed by calculating the sensitivity and specificity of UCP-CAA measurement in travellers 12 weeks after reported high-risk water contact. Routine diagnostics performed by the individual centers, such as serology, will be the standard against which sensitivity (number of cases positive in both tests / number of cases positive in routine diagnostics) and specificity (number of cases negative in both tests / number of cases negative in routine diagnostics) is calculated.
次要结局
- The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment(six weeks after praziquantel treatment)
研究者
Meta Roestenberg
M.Roestenberg, MD PhD
Leiden University Medical Center