- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640387
CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children (SickKids)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
14 days
|
|
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.
|
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
Time Frame: Within 14 days of case identification
|
The correlation between household characteristics and transmission of each of the viruses will be explored.
|
Within 14 days of case identification
|
|
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.
|
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
Time Frame: Within 14 days of case identification
|
The correlation between classroom characteristics and transmission of each virus in classrooms will be explored.
|
Within 14 days of case identification
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle Science, The Hospital for Sick Children (SickKids)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- Orthomyxoviridae Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Negative Bacterial Infections
- Pneumovirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Bordetella Infections
- COVID-19
- Influenza, Human
- Respiratory Syncytial Virus Infections
- Whooping Cough
Other Study ID Numbers
- 1000081729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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