Respiratory Syncytial Virus InfectionsNCT03698084
RESCEU: Defining the Burden of RSV Disease
An observational study of Respiratory Syncytial Virus Infections and RSV Infection, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections, RSV Infection
- What is being tested?
- venepuncture and nasopharyngeal swab
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2017to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Healthy children, gestation age at least 37+0 weeks, born at participating centres and recruited within the first week of life.
Who may be able to join
- Healthy children, gestation age at least 37+0 weeks, born at participating centres.
- Written informed consent obtained from the mother.
- Parents able and willing to adhere to protocol-specified procedures (active cohort).
Who cannot join
- Major congenital defects or serious chronic illness (i.e. severe congenital heart and/or lung disease, genetic, immunologic and/or metabolic disorder).
- Gestational age of less than 37+0 weeks.
- Acute severe medical condition at moment of sampling (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 (by parental report).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Respiratory Syncytial Virus (RSV) Disease.
This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation.
Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.
Read the detailed description
Infants will be recruited into one of two cohorts:
Passive (around 1800 participants) - Demographic data will be collected at inclusion and a parental questionnaire at one year of age. Infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent.
Active (around 200 participants) - Demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. During the infants first RSV season (Oct - May) weekly phone contact will monitor respiratory symptoms. Infants with respiratory symptoms associated with RSV (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. Infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent.
- Being tested
- venepuncture, nasopharyngeal swab
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venepunctureProcedure or surgery
sample collection for analysis
nasopharyngeal swabProcedure or surgery
sample collection for analysis
| Study group | Role | What they receive |
|---|---|---|
| Active | 200 infants enrolled; family demographics collected and samples at day 5 (venepuncture, nasopharyngeal swab, urine and stool), actively followed up through their first RSV season for signs of respiratory symptoms. If respiratory symptoms are due to RSV infection (by point of care testing) samples as taken at day 5 are repeated at time of infection and again 7 weeks later. Annual questionnaire enquiring into respiratory illness, hospitalisations and family health and health quality of life, for up to 3 years. Receives: Procedure: venepuncture; Procedure: nasopharyngeal swab | |
| Passive | 1800 infants enrolled; family demographics collected. Questionnaire follow up at 1 year of age enquiring into respiratory illness, hospitalisations and family health and health quality of life. If infant was hospitalised in first year of life, follow up will continue for up to 3 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of RSV associated Acute Respiratory Tract infections (ARTI) during the first year of life, to include the number of medically attended ARTI (MA-ARTI) and hospital admissions related to RSV.
RSV associated ARTI confirmed on nasopharyngeal swabs during home visits for all ARTI episodes during the RSV season, for testing using a RSV POC (Point of Care) test and reverse transcription-polymerase chain reaction (RT-PCR).
Participants will be screened for hospital admission for respiratory symptoms by parental questionnaire at age 1 year. If positive, RSV will be confirmed by accessing hospital records.
Medically attended RSV infection is defined as any medical care for RSV infection (defined as above)
Measured: Year 1
The relationship between infant RSV infection of different severity and school age asthma
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Measured: Year 4
The relationship between infant RSV infection of different severity and school age asthma
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Measured: Year 5
The relationship between infant RSV infection of different severity and school age asthma
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Measured: Year 6
Secondary outcomes (11)
Wheeze symptoms up to 3 years of age following RSV infection of different severity
Parent reported wheeze and doctor diagnosis of wheeze by routine care (for active birth cohort and children of passive birth cohort admitted for ARTI).
Measured: Year 1 - 3
Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).
Medically attended ARTI is defined as any medical care for a respiratory infection
Measured: Year 1
RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).
Mortality through all RSV seasons of follow up including RSV-associated deaths and all cause deaths.
Measured: Year 1 - 3
Health care costs and resource use
Health care utilisation for RSV-associated and all-cause medically attended (inpatient or outpatient) ARTI or respiratory events (active birth cohort).
Measured: Year 1 - 3
Incidence of RSV-related secondary bacterial RTIs within 21 days after onset of RSV infection and their association with antibiotic use in hospitalized RSV ARTI patients and non-hospitalized RSV ARTI patients.
The incidence of RSV-associated secondary bacterial pneumonia and associated antibiotic consumption events within 21 days after onset of RSV-related symptoms.
Measured: Within 21 days of RSV infection
To collect clinical samples (blood, nasopharyngeal, stool and urine) for biomarker analysis (active cohort).
Biomarkers associated with RSV infection in infants
Measured: Year 1
Incidence rate of other respiratory pathogens (influenza, rhinovirus, human metapneumovirus, parainfluenzavirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI (active cohort).
Additional viruses as detected by PCR testing on nasopharyngeal swab. Medically attended ARTI is defined as any medical care for a respiratory infection.
Measured: Year 1
Risk factors for RSV infection (by severity and healthcare utilisation) (active and passive cohort).
Demographic risks factors as outlined in CRF/demographic questionnaires
Measured: Year 1 - 3
The proportion of viral ARTI attributable to RSV (active cohort).
RSV and additional viruses as determined by PCR testing of nasopharyngeal swabs
Measured: Year 1
Health Related Quality of Life in RSV-associated and all-cause medically attended ARTI patients and their families (active cohort).
Annual questionnaire to families to determine interruption of normal activities associated with RSV and all-cause medically attended ARTI (active cohort).
Measured: Year 1-3
Risk factors for persistent wheeze at 3 and 6 years of age
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
Measured: Year 4,5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start5 Sep 2017
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698084
- Sponsor's protocol ID
- 2017/01
- Status last verified
- Oct 2022
- First submitted
- 19 Sep 2017
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Respiratory Syncytial Virus (RSV) Disease.
- ClinicalTrials.gov ID
- NCT03698084
- Acronym / sponsor ID
- 2017/01
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Oct 2018 (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.
This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation.
Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.
Detailed description
Infants will be recruited into one of two cohorts:
Passive (around 1800 participants) - Demographic data will be collected at inclusion and a parental questionnaire at one year of age. Infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent.
Active (around 200 participants) - Demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. During the infants first RSV season (Oct - May) weekly phone contact will monitor respiratory symptoms. Infants with respiratory symptoms associated with RSV (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. Infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | Procedure: venepuncture, Procedure: nasopharyngeal swab200 infants enrolled; family demographics collected and samples at day 5 (venepuncture, nasopharyngeal swab, urine and stool), actively followed up through their first RSV season for signs of respiratory symptoms. If respiratory symptoms are due to RSV infection (by point of care testing) samples as taken at day 5 are repeated at time of infection and again 7 weeks later. Annual questionnaire enquiring into respiratory illness, hospitalisations and family health and health quality of life, for up to 3 years. |
| Passive | – | –1800 infants enrolled; family demographics collected. Questionnaire follow up at 1 year of age enquiring into respiratory illness, hospitalisations and family health and health quality of life. If infant was hospitalised in first year of life, follow up will continue for up to 3 years. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy children, gestation age at least 37+0 weeks, born at participating centres and recruited within the first week of life.
Key inclusion criteria (3 listed)
- Healthy children, gestation age at least 37+0 weeks, born at participating centres.
- Written informed consent obtained from the mother.
- Parents able and willing to adhere to protocol-specified procedures (active cohort).
Key exclusion criteria (7 listed)
- Major congenital defects or serious chronic illness (i.e. severe congenital heart and/or lung disease, genetic, immunologic and/or metabolic disorder).
- Gestational age of less than 37+0 weeks.
- Acute severe medical condition at moment of sampling (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venepuncturesample collection for analysis | Procedure or surgery | Active |
| nasopharyngeal swabsample collection for analysis | Procedure or surgery | Active |
Primary outcome
Number of RSV associated Acute Respiratory Tract infections (ARTI) during the first year of life, to include the number of medically attended ARTI (MA-ARTI) and hospital admissions related to RSV.
Time frame: Year 1
RSV associated ARTI confirmed on nasopharyngeal swabs during home visits for all ARTI episodes during the RSV season, for testing using a RSV POC (Point of Care) test and reverse transcription-polymerase chain reaction (RT-PCR). Participants will be screened for hospital admission for respiratory symptoms by parental questionnaire at age 1 year. If positive, RSV will be confirmed by accessing hospital records. Medically attended RSV infection is defined as any medical care for RSV infection (defined as above)
The relationship between infant RSV infection of different severity and school age asthma
Time frame: Year 4
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
The relationship between infant RSV infection of different severity and school age asthma
Time frame: Year 5
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
The relationship between infant RSV infection of different severity and school age asthma
Time frame: Year 6
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
11 secondary outcomes
Wheeze symptoms up to 3 years of age following RSV infection of different severity
Time frame: Year 1 - 3
Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).
Time frame: Year 1
RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).
Time frame: Year 1 - 3
Health care costs and resource use
Time frame: Year 1 - 3
Incidence of RSV-related secondary bacterial RTIs within 21 days after onset of RSV infection and their association with antibiotic use in hospitalized RSV ARTI patients and non-hospitalized RSV ARTI patients.
Time frame: Within 21 days of RSV infection
To collect clinical samples (blood, nasopharyngeal, stool and urine) for biomarker analysis (active cohort).
Time frame: Year 1
Incidence rate of other respiratory pathogens (influenza, rhinovirus, human metapneumovirus, parainfluenzavirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI (active cohort).
Time frame: Year 1
Risk factors for RSV infection (by severity and healthcare utilisation) (active and passive cohort).
Time frame: Year 1 - 3
The proportion of viral ARTI attributable to RSV (active cohort).
Time frame: Year 1
Health Related Quality of Life in RSV-associated and all-cause medically attended ARTI patients and their families (active cohort).
Time frame: Year 1-3
Risk factors for persistent wheeze at 3 and 6 years of age
Time frame: Year 4,5 and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections and RSV Infection, run by University of Oxford at 1 site in United Kingdom.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Number of RSV associated Acute Respiratory Tract infections (ARTI) during the first year of life, to include the number of medically attended ARTI (MA-ARTI) and hospital admissions related to RSV. (time frame: Year 1). The study lists 4 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 27 Oct 2022.