Prospective Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Rate of Respiratory Syncytial Virus (RSV) Viral Clearance
研究概览
简要总结
The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in pediatric patients hospitalized with Respiratory Syncytial Virus (RSV) confirmed lower respiratory tract infection (LRTI).
详细描述
This is an exploratory prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study). The study will consist of two phases: a screening phase (Day 1) and an assessment phase (Day 2 to Day 7). During screening phase, in pediatric patients hospitalized with LRTI and from whom the informed consent form was obtained, diagnosis of RSV infection will be performed within 24h from the hospital admission, using a SOFIA POC test on nasal specimens. During the assessment phase the collection of nasal specimens will be done daily for a maximum of 6 days (Day 2 to Day 7 of hospitalization) or until patient discharge from hospital. Approximately 50 patients will be enrolled in this study. The total duration of the study for each participant will be approximately 7 days. The study duration will extend during 1-3 RSV epidemic seasons, or until the targeted number of 50 RSV hospitalized children have completed the study.
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
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legal representative has provided Ethics Committee approved written informed consent prior to any study-related procedure(s) being performed and is willing to allow the participation of child to the study for 7 consecutive days or until hospital discharge (whatever comes first)
- •Participant hospitalized with lower respiratory tract infection (LRTI) during respiratory syncytial virus (RSV) epidemics, within 24h of hospitalization. The diagnosis of LRTI will follow the standard medical procedure in the hospital unit
- •Onset of acute respiratory symptoms was less than or equal to 5 days ago
- •For the participation in the assessment phase the hospitalized participant will have an RSV confirmed infection based on SOFIA RSV point of care (POC) test
排除标准
- •Participant does not fulfill the inclusion criteria
结局指标
主要结局
Rate of Respiratory Syncytial Virus (RSV) Viral Clearance
时间窗: Day 1 to Day 3
RSV viral clearance, defined as the change in log viral load (VL) from Day 1 to Day 3, where the VL is measured in nasal specimens with quantitative reverse transcript poly cycle reaction (qRT-PCR).
次要结局
- Change From Baseline in Clinical Symptoms Score (CSS)(Day 1 (baseline) to Day 3)
- Change From Baseline in Medical Support Score (MSS)(Day 1 (baseline) to Day 3)