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

Shionogi

Status: Completed

Conditions: RSV Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT06746051

2311T1492

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: Under 36 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

100 participants in 4 patient groups

Inpatients under 1 year of age

Description:

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

Description:

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

Description:

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

Description:

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.