The Respiratory Syncytial Virus Hospitalization Surveillance Network Pilot in Japan

JRCT ID: jRCT1030230666

Registered date:29/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Acute respiratory infections
• Date of first enrollment: 15/04/2024
• Target sample size: 500
• Study type: Observational

Outcome(s)

• Primary Outcome: To evaluate operational system for RSV-NET Japan surveillance
• Secondary Outcome: To describe positivity rate, trend, clinical symptoms/signs, complication of RSV-ARI or other respiratory virus/bacteria in hospitalized ARI participants by site, age group, comorbidity and overall.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Katsumata Masayuki