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

NCT05318235 | Completed

• 1 other identifier: NL78424.041.21
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections; Coinfection

Keywords

Child; Viral interference

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• To quantify relative change in disease severity due to viral interactions.

  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

  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.

  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

  Samples and data collected during 16 weeks of follow-up

Other Outcomes (5)

• 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

• To explore the nasal microbiological community in young children

  Samples and data collected during 16 weeks of follow-up

• To examine immunity against respiratory viruses in saliva

  Samples and data collected during 16 weeks of follow-up

Study Arms (1)

Children

Children between 6 weeks and 4 years of age who have a older sibling or attend day care

Other: No intervention

Interventions

No intervention OTHER

No intervention

Children

Eligibility Criteria

• Age: 6 Weeks - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample of children living within the region of Utrecht.

You may qualify if:

• Age between 6 weeks and 4 years AND
• \) 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Midturbinate nasal swabs

MeSH Terms

Conditions

Respiratory Tract Infections; Coinfection

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Patricia Bruijning, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 8, 2022
• Study Start: September 15, 2021
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

NL (1)