RSV Infections
Conditions
Keywords
Respiratory Syncytial Virus Infections, Lower Respiratory Tract Disease (LRTD)
Brief summary
The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.
Interventions
None listed
Sponsors
Shionogi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participant who is presenting within 5 days of onset of clinical signs at the time of informed consent. * Participant is diagnosed with RSV within 5 days of sign onset. * Participant's caregiver must be able to complete daily Observer Reported Outcomes (ObsROs) and collect nasal swabs Key
Exclusion criteria
* Participant is hospitalized for reasons other than RSV infection. * Participant is considered by the PI to be immunocompromised, due to an underlying medical condition or medical therapy. * Participant has or has had a confirmed respiratory infection with another clinically relevant viral/bacterial pathogen within 14 days of study enrollment. * Participant underwent major surgery within 28 days prior to enrollment in the study or has planned major surgery within 15 days of expected study completion. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in RSV Viral Load Measurements | Day 1 to Day 21 | Viral load will be reported from results of quantitative reverse-transcription polymerase chain reaction (qRT-PCR). |
| Change From Baseline in RSV Viral Titer Measurements | Day 1 to Day 21 | Infectious viral titer will be reported from results of quantitative virus culture on adherent cells using a ViroSpot immunostaining readout. |
Countries
United States
Outcome results
None listed