Nagasaki ROAD study

JRCT ID: jRCT1070230081

Registered date:05/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute respiratory infection due to respiratory syncytial virus
• Date of first enrollment: 01/04/2024
• Target sample size: 5400
• Study type: Interventional
• Intervention(s): Biological specimen collection for RSV testing and HRQoL collection

Outcome(s)

• Primary Outcome: Occurrence of RSV-related complications, hospitalisations, and death for participants with RSV-ARI and RSV-lower respiratory tract disease (LRTD) during 180 days after Visit 1

Secondary Outcome

-Occurrence of RT-PCR-confirmed RSV-ARI and RSV-LRTD in nasopharyngeal swab samples of participants presenting with ARI at Visit 1.
-Occurrence of symptoms/signs of ARI in participants with RT-PCR-confirmed RSV-ARI and RSV-LRTD in nasopharyngeal swab samples at Visit 1.
-Score of HRQoL questionnaire (SF-12 V2) at Day 1, Day 14, and Day 180 for participants with ARI.
-Occurrence of hospitalisations, RSV-related complications, symptoms/signs of ARI, and HCRU for participants with serological-confirmed RSV-ARI and RSV-LRTD during 180 days after Visit 1.
-Occurrence of RT-PCR-confirmed respiratory viruses/bacteria other than RSV in nasopharyngeal swab samples of participants with ARI at Visit 1.
-Occurrence of the symptoms/signs of ARI, complications, hospitalisations, and deaths during 180 days after Visit 1 among participants presenting with ARI, stratified by respiratory viruses/bacteria other than RSV.

Key inclusion & exclusion criteria

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

Include criteria

-A male or female aged >- 50 years at onset of ARI.
-Participants diagnosed with at least two ARI symptoms/signs meeting the ARI case definition, for at least 12 hours, and an onset date of first symptom/sign less than 7 days before the medical visit at study sites.
-Participants who in the opinion of the investigator, can and will comply with the requirements of the study procedures (e.g., agree to provide nasopharyngeal swab samples).
-Participants who are able to provide written informed consent. If a participant is unable to write the informed consent at the time of Day 1, a family member who takes care of the participant (associated caregiver) can provide written informed consent on their behalf as a legal representative.

Exclude criteria

-Re-enrolment if new ARI symptoms/signs are reported within 14 days from the previous ARI episode.
-Participants' ARI symptoms/signs derived from aspiration pneumonia diagnosed by the investigators.
-Participant is deemed to be ineligible for the study for any other reason by the investigator or sub-investigator.

Related Information

• Primary Sponsor: Takazono Takahiro