Respiratory Syncytial Virus (RSV)NCT05622331
Burden of Respiratory Syncytial Virus (RSV) in Children in Sweden (BRICS): A Retrospective Study in Sweden
An observational study of Respiratory Syncytial Virus (RSV), run by Sanofi Pasteur, a Sanofi Company.
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- How many people
- 1,100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2006to 19 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The source population for this study will consist of all children (≤5 years of age) in Sweden with an RSV infection or any acute respiratory infection (ARI) between January 1rst 2001 and latest available date, identified from three sources: * Primary or secondary diagnosis in hospital care (National Patient Registry) * Primary or secondary diagnosis in primary care (regional databases) * Positive RSV laboratory test result (Regional laboratory data) The expected study sample is 38,000 unique pediatric patients with an RSV diagnosis, identified in the National Patient Register between 2001 and 2020. The expected RSV sample size, the non-RSV control population will consist of 80,000-160,000 individuals, matched 1:10. The expected number of ARI infections during the time period is estimated to around 1 million. This totals a study sample of between 1-1.1 million.
Who may be able to join
- •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.
Who cannot join
- •There are no exclusion criteria for this study.
About this study
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.
Read more
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).
Read the detailed 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.
- Conditions
- Respiratory Syncytial Virus (RSV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RSV cohort | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | A non-RSV control population consisting of children (<5 years of age) will be extracted to estimate the burden compared to the general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term healthcare: Number of specialist outpatient visits
Number of RSV specialist outpatient hospital visits during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: Number of hospitalizations
Number of hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: Length of hospitalizations
The length of hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations
Number of ICU hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: Length of ICU hospitalizations
The length of ICU hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: Number of RSV-related medical/surgical procedures
Number of RSV-related medical/surgical procedures during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: Number of dispensed prescriptions of RSV-related medications
Number of dispensed prescriptions of RSV-related medications during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: The costs of direct medical (in- and outpatient care)
Direct medical (in- and outpatient care) costs related to RSV infection
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Short-term healthcare: The costs of RSV-related medications
The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Medium-term healthcare: Number of specialist outpatient visits
Number of RSV specialist outpatient hospital visits during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: Number of hospitalizations
Number of hospitalizations/stays related to RSV during follow up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: Length of hospitalizations
The length of hospitalizations/stays related to RSV during follow up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations
Number of ICU hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: Length of ICU hospitalizations
The length of ICU hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: Number of RSV-related medical/surgical procedures
Number of RSV-related medical/surgical procedures during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: Number of dispensed prescriptions of RSV-related medications
Number of dispensed prescriptions of RSV-related medications during follow-up
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: The costs of direct medical (in- and outpatient care)
Direct medical (in- and outpatient care) costs related to RSV infection
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Medium-term healthcare: The costs of RSV-related medications
The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Secondary outcomes (24)
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
Measured: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period
Incidence of RSV/ARIs
Incidence of RSV/ARI per 100,000 population
Measured: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: by respiratory years
Number of laboratory-confirmed RSV cases with RSV diagnosis
Number of laboratory confirmed RSV cases with RSV diagnosis code (ICD-10)
Measured: 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 no RSV diagnosis
Number of laboratory confirmed RSV cases with no RSV diagnosis code (ICD-10)
Measured: Analysis period: July 1st 2006 - June 30th 2021Reporting period: at index date or during look-back period
Number of diagnosed RSV cases with no RSV laboratory tests conducted
Number of diagnosed RSV cases (ICD-10) with no laboratory test conducted
Measured: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period
Mortality
All-cause 30-day death from index date
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Socioeconomic burden: Net days of VAB leave
Net days of temporary parental leave (VAB) during follow-up period due to child with RSV diagnosis
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Socioeconomic burden: Net VAB leave benefit
Net temporary parental leave (VAB) benefit during follow-up period due to child with RSV diagnosis
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
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
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Proportion of patients that develop respiratory complications (ICD-10 codes)
Proportion of patients that develop respiratory complications (ICD-10 codes)
Measured: 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
Incidence of RSV per 1000 person-years in RSV, non-RSV control cohorts and rhinovirus cohorts
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Incidence rate ratios (IRR)
Incidence rate ratios (IRR) in RSV, non-RSV control and rhinovirus cohorts
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Hazard ratios (HR)
Hazard ratios (HR) in RSV, non-RSV control and rhinovirus cohorts
Measured: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
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
Measured: Analysis period: July 1st 2006 - July 31st 2021Reporting period: look back period
Primary Care: Number of primary care contacts
Number of primary care contacts during follow-up period
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Number of specialized outpatient care visits
Number of specialized outpatient care visits during follow-up period
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Number of hospitalizations
Number of hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Length of hospitalizations
Length of hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Number of ICU hospitalizations
Number of ICU hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Length of ICU hospitalizations
Length of ICU hospitalizations/stays related to RSV during follow-up
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Number of RSV-related medical/surgical procedures
Number of RSV-related medical/surgical procedures during follow-up
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Number of dispensed prescriptions of RSV-related medications
Number of dispensed prescriptions of RSV-related medications during follow-up
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: The costs of direct medical (in- and outpatient care)
Direct medical (in- and outpatient care) costs related to RSV infection
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: The costs of RSV-related medications
The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price
Measured: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Jul 2006
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quantify Research
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622331
- Sponsor's protocol ID
- RSV00046
- Other IDs
- U1111-1280-4878
- Status last verified
- May 2024
- First submitted
- 28 Oct 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Respiratory Syncytial Virus (RSV) in Children in Sweden (BRICS): A Retrospective Study in Sweden
- ClinicalTrials.gov ID
- NCT05622331
- Acronym / sponsor ID
- RSV00046
- Conditions
- Respiratory Syncytial Virus (RSV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100,000 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Quantify Research
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| RSV cohort | – | –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 | – | –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 | – | –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 | – | –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 | – | –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 | – | –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 | – | –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 | – | –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 | – | –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 | – | –A non-RSV control population consisting of children (<5 years of age) will be extracted to estimate the burden compared to the general population |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The source population for this study will consist of all children (≤5 years of age) in Sweden with an RSV infection or any acute respiratory infection (ARI) between January 1rst 2001 and latest available date, identified from three sources: * Primary or secondary diagnosis in hospital care (National Patient Registry) * Primary or secondary diagnosis in primary care (regional databases) * Positive RSV laboratory test result (Regional laboratory data) The expected study sample is 38,000 unique pediatric patients with an RSV diagnosis, identified in the National Patient Register between 2001 and 2020. The expected RSV sample size, the non-RSV control population will consist of 80,000-160,000 individuals, matched 1:10. The expected number of ARI infections during the time period is estimated to around 1 million. This totals a study sample of between 1-1.1 million.
Key inclusion criteria (1 listed)
- •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.
Key exclusion criteria (1 listed)
- •There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
24 secondary outcomes
Patient characteristics
Time frame: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period
Incidence of RSV/ARIs
Time frame: Analysis period: July 1st 2006 - June 30th 2021 Reporting period: by respiratory years
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 no RSV diagnosis
Time frame: Analysis period: July 1st 2006 - June 30th 2021Reporting period: at index date or during look-back period
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
Mortality
Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
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
Socioeconomic burden: Net VAB leave benefit
Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
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
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
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 rate ratios (IRR)
Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
Hazard ratios (HR)
Time frame: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date
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
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
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
Primary Care: Number of hospitalizations
Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
Primary Care: Length of hospitalizations
Time frame: Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV), run by Sanofi Pasteur, a Sanofi Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.