Clinical trial NCT05318235: Virus Interactions in the Respiratory Tract; a Cohort Study With Children
Official title: Virus Interactions in the Respiratory Tract; a Cohort Study With Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Coinfection
Keywords: Child
Viral interference
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 229
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of children living within the region of Utrecht.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Strength of viral interactions
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: Direction of viral interactions
timeFrame: Samples and data collected during 16 weeks of follow-up
Secondary outcomes:
measure: To quantify relative change in disease severity due to viral interactions.
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: 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
timeFrame: Samples and data collected during 16 weeks of follow-up
Other outcomes:
measure: To explore local inflammatory responses that could mediate observed virus interaction patterns and effects on disease severity
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: To explore the nasal microbiological community in young children
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: To examine immunity against respiratory viruses in saliva
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: To explore viral-bacterial interactions in young children
timeFrame: Samples and data collected during 16 weeks of follow-up
measure: To study the effect of pandemic exposure on respiratory infections and local inflammatory responses
timeFrame: Samples and data collected during 16 weeks of follow-up
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Patricia Bruijning, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: