- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06739499
Bern, Get Ready (BEready) Cohort Study for Pandemic Preparedness (BEready)
Bern, Get Ready (BEready) Population-based Cohort Study for Pandemic Preparedness: Main Study
Study Overview
Status
Detailed Description
The overall aim is to establish BEready as a 'pandemic preparedness cohort', a cohort with a well-characterised study population of households, which has an infrastructure to conduct studies about infectious diseases, and which can be rapidly mobilised to respond to a new pandemic. BEready aims to understand the epidemiology and transmission of infectious diseases (particularly viral respiratory pathogens) in households including pets in the canton of Bern, and to engage diverse communities in efforts to strengthen pandemic preparedness.
The objectives are:
- to study the distribution and timing of infectious diseases and transmission patterns of circulating infectious diseases, both between individuals and at the human-animal interface (One Health)
- to study social (e.g. gender, affective polarisation) and environmental factors (e.g. climate change), which may affect transmission or acquisition of infectious diseases;
- to understand how households, including their pets, in the canton of Bern have been and will be affected by COVID-19; and
- to engage diverse communities in ongoing efforts to strengthen pandemic and public health literacy, and to prepare for the public health response to a new pandemic.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bern, Switzerland, 3012
- University of Bern
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
BEready will include a spectrum of the Bernese population living in private households, including adults, children and pets. A private household is defined as a person living alone or group of persons living in the same dwelling.
The study population for the BEready cohort will be enrolled from different sources in the source population of the canton of Bern. BEready aims to enrol around 1,500 households in total from:
- Households already participating in the BEready pilot study
- A random selection of households in Bern using the cantonal residents' register
- Volunteer households from the general public
Description
Inclusion criteria for adults and children:
- Informed consent
- Residence (average of more than 3 days/week) in a private household in the canton of Bern where at least one member aged 18 agreed to take part.
- For adults, children aged 14 years or older, and parents/legal guardians: internet connection (Wi-Fi, fixed or on a mobile phone) and personal email address.
- For adults, children aged 11 years or older, and parents/legal guardians: able to understand, speak, read and write German, French and/or English.
Inclusion criteria for household pets: Pets of eligible household members with the consent of their owners.
Exclusion criteria for adults and children: Currently planned move outside the canton of Bern
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Response rate among the randomly sampled participants
Time Frame: Baseline
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Percentage agreeing to take part, divided by the number invited, by age and sex (study level)
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Baseline
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Attendance of follow up visits (to derive factors associated with research participation)
Time Frame: At every annual follow-up for up to 100 years
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Percentage of completed questionnaire (study level)
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At every annual follow-up for up to 100 years
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Incidence of respiratory virus detection in symptomatic persons
Time Frame: At the end of a 12 months period
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Test positivity: percentage of nasal swab samples with a positive result for specific respiratory viruses among all viruses detected amongst those reporting disease events cumulatively by the end of one year; incidence rate for any detected virus and for specific viruses: number of nasal swab samples with a positive result per 100 person years of follow-up (individual level, infection-related)
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At the end of a 12 months period
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Seroprevalence of antibodies to respiratory viruses
Time Frame: At baseline and annually thereafter for up to 100 years
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Proportion of serum samples with antibodies to specific respiratory viruses (individual level, infection-related)
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At baseline and annually thereafter for up to 100 years
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Incidence of co-infection/co-colonisation at the pet/owner interface
Time Frame: Throughout follow-up for up to 100 years
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Proportion of serum samples with antibodies to specific parasites (individual level, infection-related)
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Throughout follow-up for up to 100 years
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Incidence of animal diseases diagnosed through syndromic surveillance
Time Frame: Throughout follow-up for up to 100 years
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Based on each case definition, e.g.
febrile illness, incidence of syndromic diagnoses by month (individual level, infection-related)
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Throughout follow-up for up to 100 years
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Prevalence of post-acute viral symptoms
Time Frame: At baseline and annually thereafter for up to 100 years
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Individual level, infection-related
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At baseline and annually thereafter for up to 100 years
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|
Gender roles
Time Frame: At all timepoints for up to 100 years
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Gender is a cross-cutting theme.
Associations with gender measured by questionnaire will be examined for all endpoints (individual level, personal, social, demographic).
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At all timepoints for up to 100 years
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Number of daily social contacts
Time Frame: At baseline and annually thereafter for up to 100 years
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Numbers of social contacts between humans, according to age group and location (individual level, personal, social, demographic)
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At baseline and annually thereafter for up to 100 years
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Affective polarisation
Time Frame: At baseline
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Mean and standard deviation of Likert scale scores (individual level, personal, social, demographic)
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At baseline
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Knowledge of pandemic preparedness
Time Frame: At baseline
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Knowledge measured by questionnaire.
Summary of the survey data (individual level, personal, social, demographic)
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At baseline
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Knowledge of vector-borne diseases
Time Frame: At baseline
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Knowledge measured by questionnaire.
Summary of the survey data (individual level, personal, social, demographic)
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At baseline
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Experienced marginalisation
Time Frame: At baseline
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Experience measured by questionnaire.
Summary of the survey data (individual level, personal, social, demographic)
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At baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicola Low, Prof. Dr. med., University of Bern
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
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
Other Study ID Numbers
- 2023-02290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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