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Completed

NCT Number: NCT06746051

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

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.

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Key information

Conditions

RSV Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

SUNY Upstate Medical University, Syracuse, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/Exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Change From Baseline in RSV Viral Load Measurements

    Time frame: Day 1 to Day 21

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

  2. Change From Baseline in RSV Viral Titer Measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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