Burden of Respiratory Syncytial Virus (RSV) in Children in Sweden (BRICS): A Retrospective Study in Sweden

Sanofi

Status: Completed

Conditions: Respiratory Syncytial Virus (RSV)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05622331

U1111-1280-4878 (Registry Identifier)

RSV00046

Details and patient eligibility

About

Primary Objective:

-Estimate the hospital-associated healthcare resource use (HCRU), and associated costs, of RSV infection in children in comparison to the non-RSV control cohort (general population) and patients with rhinovirus infection.

Secondary Objectives:

• Describe demographic and clinical patient characteristics of RSV infected children.

• Estimate and compare the incidence of RSV infection and acute respiratory infections (ARIs) in children.

• Estimate the mortality associated with RSV infection in children.

• Estimate the social economic burden of RSV infection in children in relation to parents staying home from work to care for their sick child (VAB leave) in comparison to non-RSV control cohort (i.e. parents to children in the general population).

  • Estimate the net days with VAB leave and the compensation disbursed (temporary parental benefit) associated with RSV infection in children.
  • Estimate the indirect costs that can be attributed to VAB leave.

• Examine the medium- and long-term complications associated with an RSV diagnosis in children in comparison to the non-RSV control chart (general population) and patients with rhinovirus infection.

• Examine and describe risk factors associated with an RSV infection in children

• Estimate the healthcare resource use (HCRU), and associated costs, of RSV infection in children, for a subset of patients where primary care data is available, in comparison to the non-RSV control cohort (general population).

Full description

The overall study period will be between July 1st 2001 and to latest available date (likely June 30th 2022).

Patients will be identified for inclusion in the study population between July 1st 2006 and June 30th 2021.

Patients will be followed from time of inclusion until end of the study period or until death.

All patients will have an index date corresponding to the date of diagnosis of incident infection in primary and/or hospital care during the identification period. An incident infection is defined as the occurrence of infections more than 30 (>30) days apart. This implies that a patient can have more than one index date during the study period. Patients that are included in both the RSV cohort and the regional primary care RSV cohort may have two different index dates for the same incident infection, depending on the objective. This is if a patient is first treated in primary care and then hospitalized. The index date is defined differently for the two cohorts, as the first diagnosis in hospital care for the RSV cohort and first diagnosis in primary care OR hospital care for the regional primary care cohort. The non-RSV controls will have the same index date as their matched RSV patient.

The look-back period will be used to inform baseline characteristics as well as patients' medical and diagnosis history. All patients will have possible look-back from birth for information on the patient's hospital care history and from 2005 for information on the patient's prescribed drugs history. The individual look-back and follow-up will depend on the time of inclusion in the study population as well as age at inclusion.

Enrollment: 1,100,000 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

•Children (≤5 years of age) with an RSV infection or any acute respiratory infection (ARI) between July 1st 2001 and latest available date, identified in either hospital care, regional primary care or laboratory database.

Exclusion criteria

•There are no exclusion criteria for this study.

Trial design

1,100,000 participants in 10 patient groups

RSV cohort

Description:

Children (\<5 years of age at diagnosis) with a diagnosis of RSV (ICD-10 code) in hospital care between July 1st 2006 and June 30th 2021

Regional primary care RSV cohort

Description:

Children (\<5 year of age) with a diagnosis of RSV (ICD-10 code) in primary care identified in regional databases (Region Skåne, Region Halland and VGR) between July 1st 2006 and June 30th 2021

Regional laboratory RSV cohort

Description:

Children (\<5 years of age) with a positive laboratory RSV test result (multiplex/rapid PCR, antigen, immunofluorescence or immunochromatography rapid test) in primary or hospital care, identified in regional laboratory databases (Region Skåne and Region Halland) between July 1st 2006 and June 30th 2021

Acute Respiratory Infections (ARI) cohort

Description:

Children (\<5 of age) with a diagnosis of ARI (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Regional ARI cohort

Description:

Children (\<5 years of age) with a diagnosis of RSV (ICD-10 code, see Table 1) in primary care, identified in regional databases (Region Skåne, Region Halland and VGR)

Rhinovirus cohort

Description:

Children (\<5 of age) with a diagnosis of rhinovirus (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Human Metapneumovirus (HMPV) cohort

Description:

Children (\<5 of age) with a diagnosis of HMPV (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Parainfluenza cohort

Description:

Children (\<5 of age) with a diagnosis of parainfluenza (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Parent cohort

Description:

Parents to all children will be linked to the study population, which is possible through linkage between children and parents by their personal identifiers

Non-RSV control cohort

Description:

A non-RSV control population consisting of children (\<5 years of age) will be extracted to estimate the burden compared to the general population