Acute Respiratory Infection / RS Virus Infection
Conditions
Interventions
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 questionnai
Sponsors
Katsumata Masayuki
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactMasayuki Katsumata
GlaxoSmithKline K.K.
Outcome results
None listed