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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05318235
Other study ID # NL78424.041.21
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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