RSV InfectionsNCT06746051
A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants
An observational study of RSV Infections, run by Shionogi at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- RSV Infections
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be enrolled at both inpatient and outpatient clinics.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Children's Hospital
Seattle, Washington, 98105
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official 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
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)
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in RSV Viral Load Measurements
Viral load will be reported from results of quantitative reverse-transcription polymerase chain reaction (qRT-PCR).
Measured: 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.
Measured: Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start9 Dec 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionsStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746051
- Sponsor's protocol ID
- 2311T1492
- Status last verified
- Apr 2025
- First submitted
- 18 Dec 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06746051
- Acronym / sponsor ID
- 2311T1492
- Conditions
- RSV Infections
- Keywords
- Respiratory Syncytial Virus Infections, Lower Respiratory Tract Disease (LRTD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be enrolled at both inpatient and outpatient clinics.
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infections, run by Shionogi at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in RSV Viral Load Measurements (time frame: Day 1 to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.