JPRN-jRCT1030210195
Completed
N/A
A cross-sectional, multi-centre, epidemiological study to estimate the burden of respiratory syncytial virus (RSV) infection in adults aged >- 60 years, presenting with acute respiratory infection (ARI) at outpatient clinics / outpatient hospitals in Japan.
Katsumata Masayuki0 sites3,000 target enrollmentJuly 12, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Respiratory Infection / RS Virus Infection
- Sponsor
- Katsumata Masayuki
- Enrollment
- 3000
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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