跳至主要内容
临床试验/jRCT1030230666
jRCT1030230666招募中不适用

The Respiratory Syncytial Virus Hospitalization Surveillance Network Pilot in Japan (RSV-NET Japan Pilot )

GlaxoSmithKline K.K.0 个研究点目标入组 500 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
50age old over 至 No limit(—)
性别
All

入选标准

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Aged >- 50 years at onset of hospitalized ARI.
  • Hospitalized patients with two or more symptoms/signs of an ARI that meet the ARI definitions (see Section 6.1) lasting more than 12 hours
  • Patients agree to provide nasal/throat swab samples to detect RSV by multiplex-nested PCR and a combination RAT
  • Participants who are able to provide written IC. If a participant is unable to provide the IC at the time of Day1, a legal representative (family member who live together with the participant) can provide written IC on their behalf.
  • In case of a legal representative will provide, a consent form can be provided remotely via an electronic form.

排除标准

  • Participants are excluded from the study if any of the following criteria apply:
  • Hospitalized ARI participants
  • Re-enrolment if new ARI symptoms/signs are reported within 14 days from the study conclusion contact of the previous ARI.
  • Participants' ARI symptoms/signs are attributed to aspiration pneumonia diagnosed.
  • Participant who does not have a digital device such as a smartphone, computer or tablet
  • Participant is deemed to be ineligible for the study for any other reason by the investigator or sub investigator, eg. cognitive dysfunction, symptom severity that they cannot follow the procedures for study participation.

结局指标

主要结局

-

To evaluate operational system for RSV-NET Japan surveillance

次要结局

  • positivity rate
  • trend
  • clinical symptoms/signs
  • complication

研究者

发起方
GlaxoSmithKline K.K.

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