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Active, Not Recruiting

NCT Number: NCT06640387

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

SARS CoV 2 Infection Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Bordetella Pertussis, Whooping Cough COVID-19 Coronaviridae Infections Coronavirus Infections Gram-Negative Bacterial Infections Infections Influenza Influenza, Human Lung Diseases Mononegavirales Infections Mycoplasma Pneumoniae Nidovirales Infections Orthomyxoviridae Infections Paramyxoviridae Infections Pneumonia Pneumonia, Viral Pneumovirus Infections RNA Virus Infections RSV Infection Respiratory Syncytial Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Whooping Cough

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

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

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, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis

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, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis (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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 14 days

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

Secondary outcomes

  1. To assess the impact of various host factors on viral dynamics

    Time frame: 14 days

    The correlation between host factors and viral dynamics will be explored.

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

    Time frame: Within 14 days of case identification

    The number of household contacts that are tested and test positive for the same respiratory virus (influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, bordetella pertussis) will be described.

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

    Time frame: Within 14 days of case identification

    The correlation between household characteristics and transmission of each of the viruses will be explored.

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

    Time frame: Within 14 days of case identification

    The number of classmates in the classroom that are tested and test positive for the same respiratory virus (influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, bordetella pertussis) will be described.

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

    Time frame: Within 14 days of case identification

    The correlation between classroom characteristics and transmission of each virus in classrooms will be explored.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
May 1, 2026

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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