Determining the Incidence, Causes and Outcomes of Rural Febrile Illness (RFI) in South and Southeast Asia, as Part of the South and Southeast Asian Community-based Trials Network (SEACTN). Work Package A (WP-A).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 7
- 主要终点
- Local incidence of febrile illness
研究概览
简要总结
The study will collect information to understand the causes and outcomes of febrile illness in rural areas in countries across South and Southeast Asia ( including Cambodia, Laos, Myanmar and Bangladesh). The findings will be used to identify new tests and treatments that can improve the management of febrile patients in the future.
This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
详细描述
This study aims to better understand and quantify the burden of febrile illness, the aetiological causes and the manner in which it affects the people living in rural areas in South and Southeast Asia, all on a scale which has not been attempted before. The SEACTN RFI project will collect information to help better understand and predict these outcomes based on a multitude of factors, which will form the basis for interventions within the network in the future. Determining the incidence, causes and outcomes of febrile illness in these settings will be done through two work packages. The first of these, Work Package A (WP-A), the subject of this study, will be carried out at the community level, primarily by engaging village health worker (VHWs) and low-level Health Centres (HCs) which serve the communities to recruit patients presenting with a febrile illness. These patients will be assessed for presenting symptoms and followed up for clinical outcomes. Collection of specimen for diagnostic investigations in these settings is challenging. Currently, mRDTs are conducted by VHWs and HCs in these networks, therefore by using the same process, but also applying blood to filter paper and allowing it to dry (DBS), investigators will test for certain other pathogens, which will increase the aetiological yield.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented fever (≥ 37.5°C axillary), hypothermia (< 35.5°C) and/or history of fever in the last 24 hours.
- •Willingness and ability to comply with study protocol for the study duration.
- •Written informed consent given to participate in the trial.
排除标准
- •Currently enrolled in the study
- •Accident or trauma is the cause for presentation
- •Presentation ≤ 3 days after routine immunisations
结局指标
主要结局
Local incidence of febrile illness
时间窗: From Months 0 to 24
The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the village level.
Overall incidence of febrile illness
时间窗: From Months 0 to 24
The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the regional level. These estimates will later be triangulated with and extrapolated from using health seeking behavior surveys for an estimate of the total incidence of febrile illness.
Mortality
时间窗: Within approximately 1 month of first presentation to the village health worker or health facility
Case fatality rates in febrile illness
Morbidity
时间窗: Over 1 month after first presentation
Duration of illness in patients presenting with a fever to the village health worker or health facility.
次要结局
- The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.(Samples collected over approximately 24 months)
- Prevalence of pathogens in febrile patients(Samples collected over approximately 24 months)
