Acute respiratory infection due to respiratory syncytial virus
Conditions
Interventions
Biological specimen collection for RSV testing and HRQoL collection
Sponsors
Takazono Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| -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. | — |
Contacts
Public ContactTakahiro Takazono
Nagasaki University Hospital
Outcome results
None listed