Clinical trial NCT06640387: Viral Dynamics and Transmission of Influenza, RSV and SARS-CoV-2 in Children
Official title: Viral Dynamics of Influenza, RSV, and SARS-CoV-2 in Children and Secondary Transmission Within Households and Schools
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SARS CoV 2 Infection
RSV Infection
Influenza
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with acute symptomatic influenza, RSV or SARS-CoV-2 infection identified through hospital testing (inpatient, outpatient, staff household members) or the school-based take-home saliva testing program.

Brief summary: Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. In the 2022-2023, influenza, RSV and SARS-CoV-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. Unfortunately, there continues to be limited data on duration of infectiousness and transmission risk of these viruses to inform public health decisions during times when there is significant circulation of these viruses.


Eligibility criteria: Inclusion Criteria:

Viral dynamics (primary outcome):

* The child must be less than 18 years of age
* Have a positive PCR sample for influenza, RSV or SARS-CoV-2,
* Have any one of the symptoms listed to meet testing eligibility: fever, cough, shortness of breath, decreased or loss of taste or smell, muscle aches/joint pains (unusual, long lasting, not related to injury), extreme tiredness (unusual fatigue not otherwise explained), sore throat, runny or stuffy/congested nose, headache (new, unusual, long-lasting), nausea/vomiting and/or diarrhea, and
* Be within 5 days of symptom onset

Household testing inclusion criteria (secondary outcome):

-Any individual in the same household (i.e. household contacts, defined as residing at the same address) as the individual testing positive by PCR for influenza, RSV or SARS-CoV-2

Classroom testing inclusion criteria (secondary outcome):

-Any individual in the same classroom (i.e. classroom contacts) as the individual testing positive by PCR for influenza, RSV or SARS-CoV-2 (i.e. case identified through the THS program)

Exclusion Criteria:

Viral dynamics (primary outcome):

-Participants will be ineligible if they are more than 5 days from symptom onset

Primary outcomes:
measure: To describe the viral dynamics of influenza, RSV and SARS-CoV-2 over time among children <18 years of age.
timeFrame: 10 days
Secondary outcomes:
measure: To assess the impact of various host factors on viral dynamics
timeFrame: 10 days
measure: To assess the frequency of influenza, RSV and SARS-CoV-2 transmission in households.
timeFrame: Within 14 days of case identification
measure: To examine the risk factors for influenza, RSV and SARS-CoV-2 transmission in households
timeFrame: Within 14 days of case identification
measure: To assess the frequency of influenza, RSV and SARS-CoV-2 transmission in classrooms.
timeFrame: Within 14 days of case identification
measure: To examine the risk factors for influenza, RSV and SARS-CoV-2 transmission in classrooms
timeFrame: Within 14 days of case identification
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children (SickKids)
name: Michelle Science
role: PRINCIPAL_INVESTIGATOR
References: