Virus Interactions in the Respiratory Tract; a Cohort Study With Children

Respiratory Tract Infections Clinical Trial

— VIOOL  

Official title:

Virus Interactions in the Respiratory Tract; a Cohort Study With Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318235
• Other study ID #: NL78424.041.21
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: April 23, 2024

Study information

• Verified date: May 2024
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 4 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coinfection
• Respiratory Tract Infections

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore local inflammatory responses that could mediate observed virus interaction patterns and effects on disease severity		Samples and data collected during 16 weeks of follow-up
Other	To explore the nasal microbiological community in young children		Samples and data collected during 16 weeks of follow-up
Other	To examine immunity against respiratory viruses in saliva		Samples and data collected during 16 weeks of follow-up
Other	To explore viral-bacterial interactions in young children		Samples and data collected during 16 weeks of follow-up
Other	To study the effect of pandemic exposure on respiratory infections and local inflammatory responses		Samples and data collected during 16 weeks of follow-up
Primary	Strength of viral interactions	To quantify the strength of interactions between common respiratory virus infections in young children.	Samples and data collected during 16 weeks of follow-up
Primary	Direction of viral interactions	To quantify the direction of interactions between common respiratory virus	Samples and data collected during 16 weeks of follow-up
Secondary	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	Samples and data collected during 16 weeks of follow-up
Secondary	To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children		Samples and data collected during 16 weeks of follow-up
Secondary	To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.		Samples and data collected during 16 weeks of follow-up
Secondary	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		Samples and data collected during 16 weeks of follow-up