An Observational Study to Investigate Clinical Findings and Viral Load/Titer of Respiratory Syncytial Virus (RSV) Infection Over Time in Participants up to and Including 36 Months of Age

Shionogi2 sites in 1 country100 target enrollmentDecember 9, 2024

ConditionsRSV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: RSV Infections
Sponsor: Shionogi
Enrollment: 100
Locations: 2
Primary Endpoint: Change From Baseline in RSV Viral Load Measurements
Status: Completed
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 9, 2024

End Date

March 31, 2025

Last Updated

12 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shionogi

Responsible Party

Sponsor

Eligibility Criteria

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

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/Exclusion criteria may apply.