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Completed

NCT Number: NCT05622331

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

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).

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Key information

Conditions

Respiratory Syncytial Virus (RSV)

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Short-term healthcare: Number of specialist outpatient visits

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    Number of RSV specialist outpatient hospital visits during follow-up

  2. Short-term healthcare: Number of hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    Number of hospitalizations/stays related to RSV during follow-up

  3. Short-term healthcare: Length of hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    The length of hospitalizations/stays related to RSV during follow-up

  4. Short-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    Number of ICU hospitalizations/stays related to RSV during follow-up

  5. Short-term healthcare: Length of ICU hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    The length of ICU hospitalizations/stays related to RSV during follow-up

  6. Short-term healthcare: Number of RSV-related medical/surgical procedures

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    Number of RSV-related medical/surgical procedures during follow-up

  7. Short-term healthcare: Number of dispensed prescriptions of RSV-related medications

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    Number of dispensed prescriptions of RSV-related medications during follow-up

  8. Short-term healthcare: The costs of direct medical (in- and outpatient care)

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    Direct medical (in- and outpatient care) costs related to RSV infection

  9. Short-term healthcare: The costs of RSV-related medications

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price

  10. Medium-term healthcare: Number of specialist outpatient visits

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Number of RSV specialist outpatient hospital visits during follow-up

  11. Medium-term healthcare: Number of hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Number of hospitalizations/stays related to RSV during follow up

  12. Medium-term healthcare: Length of hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    The length of hospitalizations/stays related to RSV during follow up

  13. Medium-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Number of ICU hospitalizations/stays related to RSV during follow-up

  14. Medium-term healthcare: Length of ICU hospitalizations

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    The length of ICU hospitalizations/stays related to RSV during follow-up

  15. Medium-term healthcare: Number of RSV-related medical/surgical procedures

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Number of RSV-related medical/surgical procedures during follow-up

  16. Medium-term healthcare: Number of dispensed prescriptions of RSV-related medications

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Number of dispensed prescriptions of RSV-related medications during follow-up

  17. Medium-term healthcare: The costs of direct medical (in- and outpatient care)

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Direct medical (in- and outpatient care) costs related to RSV infection

  18. Medium-term healthcare: The costs of RSV-related medications

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price

Secondary outcomes

  1. Patient characteristics

    Time frame: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period

    Age at diagnosis, sex distribution, region of residence, birth weight, birth height, gestational age, mothers age at birth, high-risk conditions, parent's education, parent's income, household status

  2. Incidence of RSV/ARIs

    Time frame: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: by respiratory years

    Incidence of RSV/ARI per 100,000 population

  3. Number of laboratory-confirmed RSV cases with RSV diagnosis

    Time frame: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period

    Number of laboratory confirmed RSV cases with RSV diagnosis code (ICD-10)

  4. Number of laboratory-confirmed RSV cases with no RSV diagnosis

    Time frame: Analysis period: July 1st 2006 - June 30th 2021Reporting period: at index date or during look-back period

    Number of laboratory confirmed RSV cases with no RSV diagnosis code (ICD-10)

  5. Number of diagnosed RSV cases with no RSV laboratory tests conducted

    Time frame: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period

    Number of diagnosed RSV cases (ICD-10) with no laboratory test conducted

  6. Mortality

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

    All-cause 30-day death from index date

  7. Socioeconomic burden: Net days of VAB leave

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Net days of temporary parental leave (VAB) during follow-up period due to child with RSV diagnosis

  8. Socioeconomic burden: Net VAB leave benefit

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Net temporary parental leave (VAB) benefit during follow-up period due to child with RSV diagnosis

  9. Socioeconomic burden: Indirect costs of VAB leave due to RSV

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

    Productivity loss due to RSV-related temporary parental leave during follow-up period, calculated by human capital method and average wage

  10. Proportion of patients that develop respiratory complications (ICD-10 codes)

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date

    Proportion of patients that develop respiratory complications (ICD-10 codes)

  11. Incidence of RSV per 1000 person-years

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date

    Incidence of RSV per 1000 person-years in RSV, non-RSV control cohorts and rhinovirus cohorts

  12. Incidence rate ratios (IRR)

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date

    Incidence rate ratios (IRR) in RSV, non-RSV control and rhinovirus cohorts

  13. Hazard ratios (HR)

    Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date

    Hazard ratios (HR) in RSV, non-RSV control and rhinovirus cohorts

  14. Estimation of hazard ratio of each risk factor on being diagnosed with RSV

    Time frame: Analysis period: July 1st 2006 - July 31st 2021Reporting period: look back period

    A Cox proportional hazards regression model will be used to estimate the hazard ratio of each risk factor on being diagnosed with RSV. Predictors for RSV diagnosis presented as hazard ratios, including premature birth, high-risk conditions, APGAR, seasonality, mother's age at birth, number of children in household, birth order, parent's education, parent's income, household status, maternal smoking, mother's BMI

  15. Primary Care: Number of primary care contacts

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Number of primary care contacts during follow-up period

  16. Primary Care: Number of specialized outpatient care visits

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Number of specialized outpatient care visits during follow-up period

  17. Primary Care: Number of hospitalizations

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Number of hospitalizations/stays related to RSV during follow-up

  18. Primary Care: Length of hospitalizations

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Length of hospitalizations/stays related to RSV during follow-up

  19. Primary Care: Number of ICU hospitalizations

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Number of ICU hospitalizations/stays related to RSV during follow-up

  20. Primary Care: Length of ICU hospitalizations

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Length of ICU hospitalizations/stays related to RSV during follow-up

  21. Primary Care: Number of RSV-related medical/surgical procedures

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Number of RSV-related medical/surgical procedures during follow-up

  22. Primary Care: Number of dispensed prescriptions of RSV-related medications

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Number of dispensed prescriptions of RSV-related medications during follow-up

  23. Primary Care: The costs of direct medical (in- and outpatient care)

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    Direct medical (in- and outpatient care) costs related to RSV infection

  24. Primary Care: The costs of RSV-related medications

    Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date

    The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Collaborators

  • Quantify Research

Registry information

Important dates

Study start
2006
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2022
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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