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

NCT06746051 | Completed

• 1 other identifier: 2311T1492
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

RSV Infections

Keywords

Respiratory Syncytial Virus Infections; Lower Respiratory Tract Disease (LRTD)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in RSV Viral Load Measurements

  Viral load will be reported from results of quantitative reverse-transcription polymerase chain reaction (qRT-PCR).

  Day 1 to Day 21

• Change From Baseline in RSV Viral Titer Measurements

  Infectious viral titer will be reported from results of quantitative virus culture on adherent cells using a ViroSpot immunostaining readout.

  Day 1 to Day 21

Study Arms (4)

Inpatients under 1 year of age

Participants \<12 months of age who are PCR confirmed RSV positive and hospitalized for further evaluation of an acute respiratory tract illness will be actively enrolled with observational data collected for up to 21 days.

Outpatients under 1 year of age

Participants \<12 months of age who are PCR confirmed RSV positive and present in clinic for evaluation of an illness consistent with an acute respiratory tract infection will be actively enrolled with observational data collected for up to 21 days.

Inpatients 1 to 3 years of age inclusive

Participants ≥ 12 months to ≤ 36 months of age who are PCR confirmed RSV positive and hospitalized for further evaluation of an acute respiratory tract illness will be actively enrolled with observational data collected for up to 21 days.

Outpatients 1 to 3 years of age inclusive

Participants ≥ 12 months to ≤ 36 months of age who are PCR confirmed RSV positive and present in clinic for evaluation of an illness consistent with an acute respiratory tract infection will be actively enrolled with observational data collected for up to 21 days.

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled at both inpatient and outpatient clinics.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (2)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swabs will be collected until the participant has no signs of RSV for 48 hours but not more than 10 days after RSV diagnosis via polymerase chain reaction (PCR).

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: December 9, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)