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

UMC Utrecht

Status: Completed

Conditions: Coinfection; Respiratory Tract Infections

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05318235

NL78424.041.21

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 6 weeks to 4 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

229 participants in 1 patient group

Children

Description:

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

Treatment:

Other: No intervention