New Tools for Diagnosis and Management of Febrile Illness in Travelers to the Tropics: a Cohort Study- JOKA I
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- negative predictive value of a malaria RDT when used by travelers with febrile illness
研究概览
简要总结
This study is part of a larger prospective cohort study (JOKA), designed to study the incidence and etiological spectrum of febrile illness occurring during a travel to the tropics, as well as clinical course, care, treatment and outcome of these febrile illness episodes. Its objective is to evaluate the clinical use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a decision aid for the management of febrile illness in the tropics.
If the study demonstrates that malaria can be ruled out safely by travelers themselves using a RDT, a combination of self/peer testing with SBET may become an alternative to antimalarial chemoprophylaxis in travel medicine.
详细描述
Objectives:
To evaluate the clinical use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a decision aid for the management of febrile illness.
Design: Prospective cohort study of febrile illness in international travelers
Population: Travelers who are going to destinations in the tropics (South-East Asia (SEA), Sub-Saharan Africa (SSA) and South America (SCA)) for 3 weeks or longer will be invited to participate and, after obtaining informed consent, recruited in the study protocol(s) at the time of planning departure (directly at the ITM or through travel/ humanitarian relief organizations).
Methods: Participants will be offered pre-, per- and post-travel consultation as explained below:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •residing in Belgium
- •Attend a briefing session on the topic "Fever in The Tropics" by an ITM physician
- •able to comply with study procedures:
- •carry and complete a study diary in case of illness
- •be trained to use RDT
- •Willing and able to provide written informed consent
- •Adults fulfilling all criteria and volunteer to have their RDT collected by their trained peers during travel, may be included for analysis after obtaining informed consent upon post-travel evaluation.
排除标准
- •known intolerance or hypersensitivity to artemisinine based combination therapy
- •known pregnancy at time of travel
结局指标
主要结局
negative predictive value of a malaria RDT when used by travelers with febrile illness
时间窗: up to 12 weeks followup
malaria RDT results will be compared to post hoc PCR diagnosis of malaria on the original test strip; the negative predictive value (NPV) will be calculated in a travelers' cohort. A NPV \> 99,0 % will be considered as safe to rule out malaria.
次要结局
- Qualitative description of ease of self-/peer- use of malaria RDT, measured by a self-reported questionnaire(up to 12 weeks)
- Description of clinical symptoms and their frequencies by self-reporting(up to 12 weeks)
- self-reported management of illness in structured study diary(up to 12 weeks)
- final clinical outcome of illness(up to 12 weeks)
- Time to treatment measured from time of obtaining test results by self-reporting(up to 12 weeks)
- Duration of symptoms by self-reporting(up to 12 weeks)