NCT06746051已完成不适用
An Observational Study to Investigate Clinical Findings and Viral Load/Titer of Respiratory Syncytial Virus (RSV) Infection Over Time in Participants up to and Including 36 Months of Age
Shionogi2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change From Baseline in RSV Viral Load Measurements
研究概览
简要总结
The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.
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
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who is presenting within 5 days of onset of clinical signs at the time of informed consent.
- •Participant is diagnosed with RSV within 5 days of sign onset.
- •Participant's caregiver must be able to complete daily Observer Reported Outcomes (ObsROs) and collect nasal swabs
排除标准
- •Participant is hospitalized for reasons other than RSV infection.
- •Participant is considered by the PI to be immunocompromised, due to an underlying medical condition or medical therapy.
- •Participant has or has had a confirmed respiratory infection with another clinically relevant viral/bacterial pathogen within 14 days of study enrollment.
- •Participant underwent major surgery within 28 days prior to enrollment in the study or has planned major surgery within 15 days of expected study completion.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Change From Baseline in RSV Viral Load Measurements
时间窗: Day 1 to Day 21
Viral load will be reported from results of quantitative reverse-transcription polymerase chain reaction (qRT-PCR).
Change From Baseline in RSV Viral Titer Measurements
时间窗: Day 1 to Day 21
Infectious viral titer will be reported from results of quantitative virus culture on adherent cells using a ViroSpot immunostaining readout.
次要结局
未报告次要终点
研究者
研究点 (2)
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