RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants

UMC Utrecht

Status: Unknown

Conditions: Respiratory Syncytial Virus Infections; RSV Infection; RSV Bronchiolitis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03627572

116019-1

Details and patient eligibility

About

The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and will soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of disease RSV in young children and older adults in Europe, which is essential for stakeholders (governments, etc) to take decisions about prophylaxis and treatment.

Objective:

To determine the burden of disease due to RSV in young children.

Study design:

Prospective epidemiological, observational, multi-country, multicenter cohort study.

Study population:

Birth cohort of healthy infants (follow-up from birth until the age of 3 years maximum):

• Passive birth cohort (n=9,000).
• Active birth cohort (n=1,000).

Main study parameters/endpoints:

The primary endpoint of the study is the incidence of RSV infection-associated ARTI, RSV associated medically attended (MA) ARTI (active birth cohort) and RSV related hospitalization (passive birth cohort) in infants (< 1 year) during 3 RSV seasons. In addition, a major secondary endpoint is RSV attributable burden of wheezing.

Full description

This will be a multi-country, multicenter, prospective, observational cohort study conducted across 3 consecutive years to determine the incidence of RSV infection, RSV associated MA-ARTI and RSV related hospitalization in a birth cohort of healthy subjects, recruited from the general population.

At birth parents will be asked by a member of the study team to participate in the active cohort. If enrolled, a nasopharyngeal sample, a blood sample, a buccal sample, and urine and stool samples will be collected from the baby in the first week after birth. The blood sample will be collected by means of a heel prick or a venepuncture, if possible, in combination with an already scheduled moment of blood sampling. Respiratory tract symptoms will be assessed weekly during the RSV season by telephone or email or (daily) telephone app. If a child experiences a new episode of ARTI according to the parents, the study team will visit the child to collect a nasopharyngeal sample, 200µl is used to perform a point of care (POC) test for RSV, and the rest will be stored for additional viral testing by Reverse Transcription-Polymerase Chain Reaction (RT-PCR). If RSV is positive, parents will be asked informed consent to obtain additional blood, nasopharyngeal, urine and stool samples at the time of RSV infection and 6-8 weeks after RSV infection.

Parents of all children in the active cohort will be asked yearly to fill in a questionnaire until age 3 years maximum or till end of study (defined as the moment that the last included subject has been followed up for 12 months).

If parents decline to participate in the active birth cohort, informed consent will be asked for passive follow up. Parents of participants in passive follow-up will be asked to fill in a questionnaire at birth and after one year. If their child was admitted to the hospital because of an ARTI, clinical data will be collected retrospectively from the hospital. Participating hospitals will perform RSV tests as part of standard diagnostic care in children <1 year of age who are admitted with ARTI. Only children with hospitalization due to ARTI will be followed up by a yearly questionnaire until age 3 years maximum or till end of study (defined as the moment that the last included subject has been followed up for 12 months).

Enrollment: 10,000 estimated patients

Sex: All

Ages: Under 2 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy* children, gestation age at least 37+0, born at participating centers.
• Written informed consent obtained from parents.
• Parents ability and willingness to adhere to protocol-specified procedures (active cohort).

Exclusion criteria

• History of clinically significant medical illness including but not limited to, cardiovascular, respiratory, renal, gastrointestinal, haematologic, neurological, endocrine, immunological, musculoskeletal, oncological or congenital disorders, as judged by the investigator. Specifically excluded examples include, but are not limited to:

  • Immunosuppressed states
  • Bronchopulmonary dysplasia/chronic lung disease of infancy
  • (clinically significant) Congenital heart disease
  • Down's syndrome

• Gestational age of less than 37+0 weeks.

• Acute severe medical condition at moment of heel prick (e.g. sepsis, severe asphyxia, for which the child is admitted to the hospital).

• Child in care.

• Parents not able to understand and communicate in the local language.

• Living outside catchment area of study sites.

• Mother vaccinated against RSV during pregnancy.

Trial design

10,000 participants in 2 patient groups

Active cohort (N=1000)

Description:

Participants in this group will complete questionnaires at baseline (birth) and after 1-2-3 years. At baseline samples will be collected (blood/nasopharyngeal/urine/feces/buccal). During the RSV season(Oct-May) active sampling for RSV will be done when infants experience a respiratory infection.

Treatment:

Other: No intervention

Passive cohort (N=9000)

Description:

Parents who agree with participation in the study will be asked to fill out a questionnaire at inclusion in the first week(s) after birth and at age one year. Only children who were admitted to the hospital for ARTI during the first year of life will be followed up to the age of maximum 3 years by yearly questionnaires.

Treatment:

Other: No intervention