The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ina-Respond
- 入组人数
- 1,492
- 试验地点
- 8
- 主要终点
- The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
研究概览
简要总结
This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND hospitals. Potential study patients will be any patients (both children and adults).
详细描述
This study is an observational cohort to identify the etiologies of acute febrile illness (less than or equal to 2 weeks), which are thought to be endemic or novel in a certain area. Therefore, there are no hypotheses that require sample size calculation to be tested. It is expected that this study will enroll a minimum of 200 patients per site: approximately 100 adults and 100 pediatric cases. The final sample size is therefore estimated to be 1600.
Primary Objective:
To identify the etiology of acute febrile illness cases and evaluate clinical manifestations and outcomes.
Secondary Objectives:
- To provide clinical data that are essential for improving and/or developing clinical management and health policies.
- To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health.
- To establish a repository of biological specimens for future study, such as determining the etiology of undiagnosed fever and/or its pathogenicity and its public health importance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥1 year
- •Acute febrile illness requiring hospitalization (fever defined as temperature recorded ≥38.0°C during the first 24 hour period of hospitalization).
- •Hospitalized within the past 24 hours.
- •Willing to allow storage of blood and other specimens for use in future studies of infectious diseases.
排除标准
- •Hospitalized within the past 3 months, not including current hospitalization for acute febrile illness.
- •Inpatient transfer from another hospital.
- •A known medical disorder or other circumstance, which in the opinion of the PI might make the participation of the individual unsafe or difficult.
- •Examples include, but not limited to: mental illness which could affect compliance with protocol, an anemic patient preventing blood draw.
结局指标
主要结局
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
时间窗: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
Any pathogens identified as a caused of febrile illness based on laboratory tests such as blood culture, other culture (sputum/ pus/ urine/ feces), serology, and molecular.
次要结局
- Number of Participants With Affected Organ System by Each Specific Pathogen(3 years)
- Number of Participants Enrolled Per Each Clinical Research Site(3 years)
- Number of Vials Stored Based on Specimen Type(3 years)