Respiratory Tract InfectionsVIOOLNCT05318235
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
An observational study of Respiratory Tract Infections and Coinfection, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Read more about this study
- Who is it for?
- Ages 6 weeks to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Coinfection
- How many people
- 229 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2021to 23 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample of children living within the region of Utrecht.
Who may be able to join
- Age between 6 weeks and 4 years AND
- 1) have older siblings or 2) attend daycare. AND
- Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored
Who cannot join
- recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR
- known immunodeficiency OR
- chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR
- congenital anomalies of the airways
- Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language)
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children.
Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children.
Read more
Study design: This is a prospective observational cohort study.
Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands.
Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis.
Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
- Conditions
- Respiratory Tract Infections, Coinfection
- Being tested
- No intervention
- Keywords
- Child, Viral interference
- Medical subject headings
- Respiratory Tract Infections, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Children | Children between 6 weeks and 4 years of age who have a older sibling or attend day care Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of viral interactions
To quantify the strength of interactions between common respiratory virus infections in young children.
Measured: Samples and data collected during 16 weeks of follow-up
Direction of viral interactions
To quantify the direction of interactions between common respiratory virus
Measured: Samples and data collected during 16 weeks of follow-up
Secondary outcomes (4)
To quantify relative change in disease severity due to viral interactions.
This will be measured as changes in disease severity scores of one virus infection upon recent exposure to another virus infection
Measured: Samples and data collected during 16 weeks of follow-up
To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children
Measured: Samples and data collected during 16 weeks of follow-up
To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.
Measured: Samples and data collected during 16 weeks of follow-up
To quantify the changes in viral exposure in the pandemic-to-post-pandemic transition period and study effects of these changes on viral interaction patterns
Measured: Samples and data collected during 16 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start15 Sep 2021
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Bruijning-Verhagen, UMC Utrecht
- Investigators
- Patricia Bruijning, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318235
- Sponsor's protocol ID
- NL78424.041.21
- Acronym
- VIOOL
- Status last verified
- May 2024
- First submitted
- 17 Mar 2022
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virus Interactions in the Respiratory Tract; a Cohort Study With Children
- ClinicalTrials.gov ID
- NCT05318235
- Acronym / sponsor ID
- VIOOL / NL78424.041.21
- Conditions
- Respiratory Tract Infections, Coinfection
- Keywords
- Child, Viral interference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children.
Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children.
Study design: This is a prospective observational cohort study.
Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands.
Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis.
Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: No interventionChildren between 6 weeks and 4 years of age who have a older sibling or attend day care |
Who may qualify
- Ages
- 6 weeks to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample of children living within the region of Utrecht.
Key inclusion criteria (3 listed)
- Age between 6 weeks and 4 years AND
- 1) have older siblings or 2) attend daycare. AND
- Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored
Key exclusion criteria (5 listed)
- recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR
- known immunodeficiency OR
- chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR
- congenital anomalies of the airways
- Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Children |
Primary outcome
Strength of viral interactions
Time frame: Samples and data collected during 16 weeks of follow-up
To quantify the strength of interactions between common respiratory virus infections in young children.
Direction of viral interactions
Time frame: Samples and data collected during 16 weeks of follow-up
To quantify the direction of interactions between common respiratory virus
4 secondary outcomes
To quantify relative change in disease severity due to viral interactions.
Time frame: Samples and data collected during 16 weeks of follow-up
To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children
Time frame: Samples and data collected during 16 weeks of follow-up
To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.
Time frame: Samples and data collected during 16 weeks of follow-up
To quantify the changes in viral exposure in the pandemic-to-post-pandemic transition period and study effects of these changes on viral interaction patterns
Time frame: Samples and data collected during 16 weeks of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Bruijning, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Coinfection, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength of viral interactions (time frame: Samples and data collected during 16 weeks of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.