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

Sponsor
UMC Utrecht (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05318235
Collaborator
(none)
150
1
18.5
8.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Children

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

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Strength of viral interactions [Samples and data collected during 16 weeks of follow-up]

    To quantify the strength of interactions between common respiratory virus infections in young children.

  2. Direction of viral interactions [Samples and data collected during 16 weeks of follow-up]

    To quantify the direction of interactions between common respiratory virus

Secondary Outcome Measures

  1. To quantify relative change in disease severity due to viral interactions. [Samples and data collected during 16 weeks of follow-up]

    This will be measured as changes in disease severity scores of one virus infection upon recent exposure to another virus infection

  2. 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]

  3. 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]

Other Outcome Measures

  1. 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]

  2. To explore the nasal microbiological community in young children [Samples and data collected during 16 weeks of follow-up]

  3. To examine immunity against respiratory viruses in saliva [Samples and data collected during 16 weeks of follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Weeks to 4 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 UMC Utrecht Utrecht Netherlands 3584 CX

Sponsors and Collaborators

  • UMC Utrecht

Investigators

  • Principal Investigator: Patricia Bruijning, MD PhD, UMC Utrecht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patricia Bruijning-Verhagen, Principal investigator, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT05318235
Other Study ID Numbers:
  • NL78424.041.21
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Patricia Bruijning-Verhagen, Principal investigator, UMC Utrecht
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022