Estimation of Prevalence of and Risk Factor for Respiratory Viruses Among Emergently Admitted Adult Patients With Respiratory Symptoms and Their Influence on Clinical Outcomes in the Settings From Rural to Urban Community Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,067
- 试验地点
- 3
- 主要终点
- RS virus infection
研究概览
简要总结
Study design is multicenter prospective registry study. Participants are consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria.
The primary objectives are to estimate the prevalence of and risk factors for RS and other respiratory virus infection and their effect on hospital course in patients with any respiratory symptom who admit from emergency room using a multicenter prospective registry study. The primary target virus is RS virus and the secondary target viruses are respiratory virus and other microorganisms measured by FilmArray 2.1.
详细描述
The investigators register consecutive patients who meet the eligibility criteria at 3 participating hospitals from electronic medical records. As a routine clinical practice, presence of respiratory symptoms using standard electronic medical record (EMR) format are universally assessed at the emergency room when the patients are determined to be admitted. Patients are registered if they meet the eligibility criteria and information of medical history, baseline characteristics, living status, physical findings, laboratory tests, chest X-ray, electrocardiogram, on admission are retrieved from the EMRs. The nasopharyngeal swab is obtained within 24 hours after admission as a standard practice, which will be sampled at either emergency rooms or hospital wards. The swab is transferred to the onsite laboratory office to measure the FilmArray 2.1 by trained technicians or physicians in charge.
Serum antibodies for RS virus are obtained from patients with suspected lower respiratory infection (bronchitis and pneumonia) who provided their written informed consent, at the timing of admission and 4 weeks after the admission.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or older
- •Admission from emergency room
- •Having at least one of following respiratory symptoms/signs for at least 24 hours and the onset date of first symptom/sign less than 7 days before admission, which meet the acute respiratory infection (ARI) case definition described below: nasal congestion, rhinorrhea, sore throat, cough, sputum, dyspnea, wheeze, crackles or rhonchi, tachypnea (>=20 per minute), decreased saturation of oxygen (< 95%), admission with oxygen supplementation
排除标准
- •Scheduled admission
- •Admission for trauma care
- •With nasopharyngeal cavity diseases or deformity which block the nasopharyngeal sampling
- •Admission for end of life
- •Decline to participate the study by either informed consent or opt-out method
结局指标
主要结局
RS virus infection
时间窗: On admission
Presence of RS virus infection measured by FilmArray 2.1
次要结局
- All-cause readmission(180 days)
- Respiratory virus and other microorganisms(On admission)
- Changes in modified Rankin Scale(30 days)
- Presence of decreased oxygen saturation(30 days)
- Lower respiratory tract infections(On admission)
- Presence of cough(30 days)
- All-cause mortality(180 days)
- Presence of dyspnea(30 days)
- Presence of crackles or rhonchi(30 days)
- Presence of family member who attends preschool or school(On admission)
- RS virus infection measured by paired serologic tests(4 weeks)
- Length of hospital stay(30 days)
- Changes in clinical frailty scale(30 days)
- Changes in functional oral intake score(30 days)
- Presence of nasal congestion or rhinorrhea(30 days)
- Presence of wheeze(30 days)
- Presence of tachypnea(30 days)
- Admission to intensive or high care unit(30 days)
- Presence of sore throat(30 days)
- Presence of sputum(30 days)
- Presence of oxygen supplementation(30 days)
- Length from onset to admission of acute respiratory infection symptoms(7 days)
- Presence of symptoms of family member(On admission)
- Use of antimicrobials(30 days)
- Respiratory complications(30 days)
- Cardiovascular complications(30 days)
- Cerebrovascular complications(30 days)