A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants

Completed

• Conditions: RSV Infections

• Registration Number: NCT06746051
• Lead Sponsor: Shionogi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-09
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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/Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States