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

Respiratory Syncytial Virus (RSV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622331
• Other study ID #: RSV00046
• Secondary ID: U1111-1280-4878
• Status: Completed
• Start date: July 1, 2006
• Est. completion date: April 19, 2024

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100000
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)
• Virus Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company	Quantify Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term healthcare: Number of specialist outpatient visits	Number of RSV specialist outpatient hospital visits during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: Number of hospitalizations	Number of hospitalizations/stays related to RSV during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: Length of hospitalizations	The length of hospitalizations/stays related to RSV during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations	Number of ICU hospitalizations/stays related to RSV during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: Length of ICU hospitalizations	The length of ICU hospitalizations/stays related to RSV during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: Number of RSV-related medical/surgical procedures	Number of RSV-related medical/surgical procedures during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: Number of dispensed prescriptions of RSV-related medications	Number of dispensed prescriptions of RSV-related medications during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: The costs of direct medical (in- and outpatient care)	Direct medical (in- and outpatient care) costs related to RSV infection	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Short-term healthcare: The costs of RSV-related medications	The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Primary	Medium-term healthcare: Number of specialist outpatient visits	Number of RSV specialist outpatient hospital visits during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: Number of hospitalizations	Number of hospitalizations/stays related to RSV during follow up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: Length of hospitalizations	The length of hospitalizations/stays related to RSV during follow up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations	Number of ICU hospitalizations/stays related to RSV during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: Length of ICU hospitalizations	The length of ICU hospitalizations/stays related to RSV during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: Number of RSV-related medical/surgical procedures	Number of RSV-related medical/surgical procedures during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: Number of dispensed prescriptions of RSV-related medications	Number of dispensed prescriptions of RSV-related medications during follow-up	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: The costs of direct medical (in- and outpatient care)	Direct medical (in- and outpatient care) costs related to RSV infection	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Primary	Medium-term healthcare: The costs of RSV-related medications	The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Secondary	Patient characteristics	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	Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period
Secondary	Incidence of RSV/ARIs	Incidence of RSV/ARI per 100,000 population	Analysis period: July 1st 2006 - June 30th 2021 Reporting period: by respiratory years
Secondary	Number of laboratory-confirmed RSV cases with RSV diagnosis	Number of laboratory confirmed RSV cases with RSV diagnosis code (ICD-10)	Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period
Secondary	Number of laboratory-confirmed RSV cases with no RSV diagnosis	Number of laboratory confirmed RSV cases with no RSV diagnosis code (ICD-10)	Analysis period: July 1st 2006 - June 30th 2021Reporting period: at index date or during look-back period
Secondary	Number of diagnosed RSV cases with no RSV laboratory tests conducted	Number of diagnosed RSV cases (ICD-10) with no laboratory test conducted	Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period
Secondary	Mortality	All-cause 30-day death from index date	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Secondary	Socioeconomic burden: Net days of VAB leave	Net days of temporary parental leave (VAB) during follow-up period due to child with RSV diagnosis	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Secondary	Socioeconomic burden: Net VAB leave benefit	Net temporary parental leave (VAB) benefit during follow-up period due to child with RSV diagnosis	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Secondary	Socioeconomic burden: Indirect costs of VAB leave due to RSV	Productivity loss due to RSV-related temporary parental leave during follow-up period, calculated by human capital method and average wage	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Secondary	Proportion of patients that develop respiratory complications (ICD-10 codes)	Proportion of patients that develop respiratory complications (ICD-10 codes)	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Secondary	Incidence of RSV per 1000 person-years	Incidence of RSV per 1000 person-years in RSV, non-RSV control cohorts and rhinovirus cohorts	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Secondary	Incidence rate ratios (IRR)	Incidence rate ratios (IRR) in RSV, non-RSV control and rhinovirus cohorts	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Secondary	Hazard ratios (HR)	Hazard ratios (HR) in RSV, non-RSV control and rhinovirus cohorts	Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Secondary	Estimation of hazard ratio of each risk factor on being diagnosed with RSV	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	Analysis period: July 1st 2006 - July 31st 2021Reporting period: look back period
Secondary	Primary Care: Number of primary care contacts	Number of primary care contacts during follow-up period	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Number of specialized outpatient care visits	Number of specialized outpatient care visits during follow-up period	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Number of hospitalizations	Number of hospitalizations/stays related to RSV during follow-up	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Length of hospitalizations	Length of hospitalizations/stays related to RSV during follow-up	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Number of ICU hospitalizations	Number of ICU hospitalizations/stays related to RSV during follow-up	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Length of ICU hospitalizations	Length of ICU hospitalizations/stays related to RSV during follow-up	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Number of RSV-related medical/surgical procedures	Number of RSV-related medical/surgical procedures during follow-up	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: Number of dispensed prescriptions of RSV-related medications	Number of dispensed prescriptions of RSV-related medications during follow-up	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: The costs of direct medical (in- and outpatient care)	Direct medical (in- and outpatient care) costs related to RSV infection	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Secondary	Primary Care: The costs of RSV-related medications	The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price	Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date