An epidemiological study to estimate the burden of respiratory syncytial virus (RSV) infection in adults aged >- 60 years with acute respiratory infection (ARI), in Japan.

JRCT ID: jRCT1030210195

Registered date:12/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acute Respiratory Infection / RS Virus Infection
• Date of first enrollment: 04/08/2021
• Target sample size: 3000
• Study type: Interventional
• Intervention(s): Collection of nasal and throat swabs for the detection and identification of a panel of respiratory viruses including RSV. Completion of ARI symptoms and medication diary card and HRQoL questionnaires.

Outcome(s)

• Primary Outcome: Occurrence of RT-PCR confirmed RSV-ARI in combined nasal and throat swab samples of participants presenting with ARI, from samples collected at Visit 1 (Day 1).

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- A male or female aged >- 60 years at onset of ARI.
- Participants diagnosed with at least 2 ARI symptoms/signs meeting the ARI case definition, for at least 24 hours, and an onset date of first symptom/sign less than 10 days before the medical visit at an outpatient clinic/outpatient hospital.
- Participants who in the opinion of the investigator, can and will comply with the requirements of the study procedures (e.g. agree to provide nasal and throat swab samples, complete self-administered questionnaires, attend regular phone calls, etc.).
- Participants who are able to provide written informed consent.

Exclude criteria

- History of vaccination with an investigational RSV vaccine and administration of any RSV drugs or planned administration, anytime during the study period.
Note: Any RSV drug includes any investigational, preventative or curative drug targeting RSV specifically (including biological products such as vaccines).
- Participants with a known cognitive impairment (based on the medical judgement of the investigator).
- Re-enrolment if new ARI symptoms/signs are reported within 7 days from the resolution of the previous ARI or before study conclusion of the previous ARI episode.

Related Information

• Primary Sponsor: Katsumata Masayuki