CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools

NCT06640387 | Active Not Recruiting

• 1 other identifier: 1000081729
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS CoV 2 Infection; RSV Infection; Influenza; Mycoplasma Pneumoniae; Bordetella Pertussis, Whooping Cough

Outcome Measures

Primary Outcomes (1)

• To describe the viral dynamics of influenza, RSV and SARS-CoV-2 over time among children <18 years of age.

  The correlation between symptom onset and symptom resolution and viral load for each virus will be described.

  14 days

Secondary Outcomes (5)

• To assess the impact of various host factors on viral dynamics

  14 days

• To assess the frequency of influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in households.

  Within 14 days of case identification

• To examine the risk factors for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in households

  Within 14 days of case identification

• To assess the frequency of influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in classrooms.

  Within 14 days of case identification

• To examine the risk factors for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in classrooms

  Within 14 days of case identification

Interventions

Daily Influenza, RSV or SARS-CoV-2 PCR testing for 14 days DIAGNOSTIC_TEST

Each participant will undergo daily PCR testing for Influenza, RSV or SARS-CoV-2 to assess viral dynamics

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with acute symptomatic influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis infection identified through hospital testing (inpatient, outpatient, staff household members) or the school-based take-home saliva testing program.

You may qualify if:

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

You may not qualify if:

• Viral dynamics (primary outcome):
• Participants will be ineligible if they are more than 5 days from symptom onset

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Respiratory samples (e.g. saliva, nasal, nasopharyngeal specimens) for future respiratory infection testing (no human genetic testing)

MeSH Terms

Conditions

COVID-19; Respiratory Syncytial Virus Infections; Influenza, Human; Whooping Cough

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Orthomyxoviridae Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Michelle Science

  The Hospital for Sick Children (SickKids)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 10, 2024
• Primary Completion: April 2, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be made available once the study is complete and published.
• Access Criteria: upon request with appropriate approvals

Locations

CA (1)