RSV InfectionNCT03627572
RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants
An observational study of RSV Infection and Respiratory Syncytial Virus Infections, run by UMC Utrecht at 5 sites in 4 countries.
Trial summary
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. Read more about this study
- Who is it for?
- Ages Up to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- RSV Infection, Respiratory Syncytial Virus Infections, RSV Bronchiolitis
- How many people
- 10,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 21 Jul 2017to 31 Dec 2021
- 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 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Birth cohort of 10,000 healthy term infants of the general population including a nested (active) cohort of 1,000 healthy term infants. Subjects will be recruited from maternity wards during the first days after birth in the following countries: the Netherlands (UMCU), United Kingdom (UEDIN, UOXF), Spain (Sergas) and Finland (TUH).
Who may be able to join
- Healthy* children, gestation age at least 37+0, born at participating centers.
- Written informed consent obtained from parents.
- Parents ability and willingness to adhere to protocol-specified procedures (active cohort).
Who cannot join
- History of clinically significant medical illness including but not limited to, cardiovascular, respiratory, renal, gastrointestinal, haematologic, neurological, endocrine, immunological, musculoskeletal, oncological or congenital disorders, as judged by the investigator. Specifically excluded examples include, but are not limited to:
- Immunosuppressed states
- Bronchopulmonary dysplasia/chronic lung disease of infancy
- (clinically significant) Congenital heart disease
- Down's syndrome
- Gestational age of less than 37+0 weeks.
Show all 11Show fewer
- Acute severe medical condition at moment of heel prick (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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United Kingdom2 sites
University of Edinburgh
Edinburgh
University of Oxford, Oxford Vaccine Group
Oxford, OX3 7LE
Finland1 site
Varsinais-Suomen sairaanhoitopiirin kuntayhtymä (Turku University Hospital)
Turku, FI-20520
About this study
Official title: REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe.
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and will soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of disease RSV in young children and older adults in Europe, which is essential for stakeholders (governments, etc) to take decisions about prophylaxis and treatment.
Objective:
Read more
To determine the burden of disease due to RSV in young children.
Study design:
Prospective epidemiological, observational, multi-country, multicenter cohort study.
Study population:
Birth cohort of healthy infants (follow-up from birth until the age of 3 years maximum):
- Passive birth cohort (n=9,000).
- Active birth cohort (n=1,000).
Main study parameters/endpoints:
The primary endpoint of the study is the incidence of RSV infection-associated ARTI, RSV associated medically attended (MA) ARTI (active birth cohort) and RSV related hospitalization (passive birth cohort) in infants (< 1 year) during 3 RSV seasons. In addition, a major secondary endpoint is RSV attributable burden of wheezing.
Read the detailed description
This will be a multi-country, multicenter, prospective, observational cohort study conducted across 3 consecutive years to determine the incidence of RSV infection, RSV associated MA-ARTI and RSV related hospitalization in a birth cohort of healthy subjects, recruited from the general population.
At birth parents will be asked by a member of the study team to participate in the active cohort. If enrolled, a nasopharyngeal sample, a blood sample, a buccal sample, and urine and stool samples will be collected from the baby in the first week after birth. The blood sample will be collected by means of a heel prick or a venepuncture, if possible, in combination with an already scheduled moment of blood sampling. Respiratory tract symptoms will be assessed weekly during the RSV season by telephone or email or (daily) telephone app. If a child experiences a new episode of ARTI according to the parents, the study team will visit the child to collect a nasopharyngeal sample, 200µl is used to perform a point of care (POC) test for RSV, and the rest will be stored for additional viral testing by Reverse Transcription-Polymerase Chain Reaction (RT-PCR). If RSV is positive, parents will be asked informed consent to obtain additional blood, nasopharyngeal, urine and stool samples at the time of RSV infection and 6-8 weeks after RSV infection.
Parents of all children in the active cohort will be asked yearly to fill in a questionnaire until age 3 years maximum or till end of study (defined as the moment that the last included subject has been followed up for 12 months).
If parents decline to participate in the active birth cohort, informed consent will be asked for passive follow up. Parents of participants in passive follow-up will be asked to fill in a questionnaire at birth and after one year. If their child was admitted to the hospital because of an ARTI, clinical data will be collected retrospectively from the hospital. Participating hospitals will perform RSV tests as part of standard diagnostic care in children <1 year of age who are admitted with ARTI. Only children with hospitalization due to ARTI will be followed up by a yearly questionnaire until age 3 years maximum or till end of study (defined as the moment that the last included subject has been followed up for 12 months).
- Being tested
- No intervention
- Keywords
- RESCEU (consortium), Burden of Disease
- 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.
No interventionOther
Not applicable (no intervention)
| Study group | Role | What they receive |
|---|---|---|
| Active cohort (N=1000) | Participants in this group will complete questionnaires at baseline (birth) and after 1-2-3 years. At baseline samples will be collected (blood/nasopharyngeal/urine/feces/buccal). During the RSV season(Oct-May) active sampling for RSV will be done when infants experience a respiratory infection. Receives: Other: No intervention | |
| Passive cohort (N=9000) | Parents who agree with participation in the study will be asked to fill out a questionnaire at inclusion in the first week(s) after birth and at age one year. Only children who were admitted to the hospital for ARTI during the first year of life will be followed up to the age of maximum 3 years by yearly questionnaires. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a Medically attended RSV acute lower respiratory tract infection (MA-RSV-ALRI) based on a positive RT-PCR for RSV who visit a clinician during the RSV-ALRI.
Lower respiratory tract infection proven to be caused by RSV for which medical consultation (general practitioner/specialist/hospitalization) is required. RSV infection is confirmed using RT-PCR from a nasal swab collected by the study team in the active cohort in case of respiratory infection. In the passive cohort, this information is collected from medical data from the hospital in case of hospitalization.
Measured: In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)
Number of participants with a RSV hospitalization (hospitalization with RT-PCR confirmed RSV).
Hospitalization for a respiratory tract infection proven to be caused by RSV. This information is collected from the hospital data. RSV must be confirmed by RT-PCR.
Measured: In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)
Number of participants with an RSV infection
Incidence of RSV outside of the medical setting (active cohort only). When participants experience respiratory symptoms, the study team plans a visit to perform RSV diagnostics (nasopharyngeal swab).
Measured: Active cohort only, during the RSV season (Oct-May)
Secondary outcomes (11)
RSV-related wheeze incidence
To estimate the incidence and frequency of RSV-related wheeze up to age 3 years. Wheeze will be assessed in questionnaires during the winter season follow-up (active cohort) and after the one, two and three years of follow-up (active and passive cohort).
Measured: The incidence of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for ARTI) maximum or till end of study.
RSV related wheeze sequelae
To estimate how RSV infection of different severity relates to occurence of wheeze up to age 3 years. Wheeze will be assessed in questionnaires during follow-up (active cohort) and after the one year of follow-up (active and passive cohort). Severity characteristics of wheeze are asked such as wheeze without other symptoms and medically attended wheeze.
Measured: Severity of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for ARTI) maximum or till end of study.
All cause MA-ARTI
To determine the rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).To determine mortality (RSV associated and all-cause) through all RSV seasons of follow up (all).
Measured: annual questionnaire at age 1 year (all participants)
Effect of RSV on health care cost
To determine health care costs and health care resource use in RSV-associated and all-cause medically attended (inpatient or outpatient) ARTI patients. Data is collected on hospitalization, duration of hospitalization, treatment given (respiratory support, antibiotics) and outpatient visits.
Measured: Questionnaires during the first year of life (all), and up to 3 years of age (active cohort, RSV+ cases)
Effect of all-cause ARTI on health care cost
To determine health care costs and health care resource use in all-cause medically attended (inpatient or outpatient) ARTI patients. Data is collected on hospitalization, duration of hospitalization, treatment given (respiratory support, antibiotics) and outpatient visits.
Measured: Questionnaires during the first year of life (all), and up to 3 years of age (active cohort)
RSV related secondary bacterial infections and the use of antibiotics
To determine the incidence of RSV-related secondary bacterial respiratory tract infections within 21 days after onset of RSV infection and their association with antibiotic use in hospitalized RSV ARTI patients (all children) and non-hospitalized RSV ARTI patients (active cohort).
Measured: Hospitalization case report form (CRF) (1 year, all participants), active follow-up during the RSV season in the first year of life in the active cohort.
Sample collection for biomarker research (blood, nasal swab, nasopharyngeal swab, urine, faeces, buccal swab)
To collect clinical samples (blood, nasal swab, nasopharyngeal swab, urine, faeces, buccal swab) for biomarker analysis. This is collected at baseline (around the 5th day of life) for active participants and in case of an RSV infection during the winter season.
Measured: This is collected at baseline (around the 5th day of life) for active participants and in case of an RSV infection during the winter season.
Incidence of other respiratory pathogens
To determine the incidence rate of other respiratory pathogens (influenza, rhinovirus, human metapneumovirus, parainfluenzavirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI (active cohort).
Measured: Hospitalization CRF (1 year all participants)
Proportion of RSV in viral ARTI
To determine the proportion of viral ARTI attributable to RSV (active cohort).
Measured: active follow-up during the RSV season in the first year of life in the active cohort.
Risk factors for (severe) RSV infection
To determine important risk factors for RSV infection. Clinical risk factors will be assessed to see their association with severe RSV infection, defined as RSV-related hospitalization.
Measured: Questionnaires baseline/1 year/hospitalization, for all participants
Effect of RSV on Health-Related Quality of Life (HRQoL)
Effect of an RSV infection on the quality of life of the child and it's parents. In various questionnaires the standardized EuroQol questionnaire is used to assess the quality of life. The questionnaire contains questions on mobility, self-care, usual activities, pain/discomfort, anxiety and worries about the child, as well as a scale to assess their current health and the health of their child from 0-100 (0 being the worst health imaginable, and 100 the best health possible).
Measured: Quality of Life is assessed at baseline, during the RSV season and after 1,2,3 years of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start21 Jul 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Edinburgh, University of Turku, Servicio Gallego de Salud
- Responsible party
- Principal investigator, Louis Bont, UMC Utrecht
- Investigators
- Louis Bont, Prof. Dr., Principal investigator, University Medical Centre Utrecht (UMCU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627572
- Sponsor's protocol ID
- 116019-1
- Status last verified
- Jun 2021
- First submitted
- 18 Jul 2018
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During the course of the study, individual participant data (IPD) will only be available for researchers within the consortium.
Publications
Hak SF, Venekamp RP, Billard MN, Cianci D, Van Houten MA, Pollard AJ, Heikkinen T, Cunningham S, Millar M, Martinon-Torres F, Dacosta-Urbieta A, Bont LJ, Wildenbeest JG; PROMISE Investigators. Antibiotic use attributable to RSV infections during infancy-an international prospective birth cohort study. J Antimicrob Chemother. 2025 Jul 1;80(7):1803-1812. doi: 10.1093/jac/dkaf123.
PubMed 40343736Hak SF, Venekamp RP, Billard MN, van Houten MA, Pollard AJ, Heikkinen T, Cunningham S, Millar M, Martinon-Torres F, Dacosta-Urbieta A, Bont LJ, Wildenbeest JG; PROMISE Investigators. Substantial Burden of Nonmedically Attended RSV Infection in Healthy-Term Infants: An International Prospective Birth Cohort Study. J Infect Dis. 2024 Mar 1;229(1):S40-S50. doi: 10.1093/infdis/jiad477.
PubMed 38424744Wildenbeest JG, Billard MN, Zuurbier RP, Korsten K, Langedijk AC, van de Ven PM, Snape MD, Drysdale SB, Pollard AJ, Robinson H, Heikkinen T, Cunningham S, O'Neill T, Rizkalla B, Dacosta-Urbieta A, Martinon-Torres F, van Houten MA, Bont LJ; RESCEU Investigators. The burden of respiratory syncytial virus in healthy term-born infants in Europe: a prospective birth cohort study. Lancet Respir Med. 2023 Apr;11(4):341-353. doi: 10.1016/S2213-2600(22)00414-3. Epub 2022 Nov 10.
PubMed 36372082Wildenbeest JG, Zuurbier RP, Korsten K, van Houten MA, Billard MN, Derksen-Lazet N, Snape MD, Drysdale SB, Robinson H, Pollard AJ, Heikkinen T, Cunningham S, Leach A, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Gomez-Carballa A, Bont LJ; RESCEU Investigators. Respiratory Syncytial Virus Consortium in Europe (RESCEU) Birth Cohort Study: Defining the Burden of Infant Respiratory Syncytial Virus Disease in Europe. J Infect Dis. 2020 Oct 7;222(Suppl 7):S606-S612. doi: 10.1093/infdis/jiaa310.
PubMed 32794574Lin GL, Golubchik T, Drysdale S, O'Connor D, Jefferies K, Brown A, de Cesare M, Bonsall D, Ansari MA, Aerssens J, Bont L, Openshaw P, Martinon-Torres F, Bowden R, Pollard AJ; RESCEU Investigators. Simultaneous Viral Whole-Genome Sequencing and Differential Expression Profiling in Respiratory Syncytial Virus Infection of Infants. J Infect Dis. 2020 Oct 7;222(Suppl 7):S666-S671. doi: 10.1093/infdis/jiaa448.
PubMed 32702120
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. 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 Disease of Respiratory Syncytial Virus in Europe.
- ClinicalTrials.gov ID
- NCT03627572
- Acronym / sponsor ID
- 116019-1
- Keywords
- RESCEU (consortium), Burden of Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University of Oxford, University of Edinburgh, University of Turku, Servicio Gallego de Salud
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Aug 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.
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and will soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of disease RSV in young children and older adults in Europe, which is essential for stakeholders (governments, etc) to take decisions about prophylaxis and treatment.
Objective:
To determine the burden of disease due to RSV in young children.
Study design:
Prospective epidemiological, observational, multi-country, multicenter cohort study.
Study population:
Birth cohort of healthy infants (follow-up from birth until the age of 3 years maximum):
- Passive birth cohort (n=9,000).
- Active birth cohort (n=1,000).
Main study parameters/endpoints:
The primary endpoint of the study is the incidence of RSV infection-associated ARTI, RSV associated medically attended (MA) ARTI (active birth cohort) and RSV related hospitalization (passive birth cohort) in infants (< 1 year) during 3 RSV seasons. In addition, a major secondary endpoint is RSV attributable burden of wheezing.
Detailed description
This will be a multi-country, multicenter, prospective, observational cohort study conducted across 3 consecutive years to determine the incidence of RSV infection, RSV associated MA-ARTI and RSV related hospitalization in a birth cohort of healthy subjects, recruited from the general population.
At birth parents will be asked by a member of the study team to participate in the active cohort. If enrolled, a nasopharyngeal sample, a blood sample, a buccal sample, and urine and stool samples will be collected from the baby in the first week after birth. The blood sample will be collected by means of a heel prick or a venepuncture, if possible, in combination with an already scheduled moment of blood sampling. Respiratory tract symptoms will be assessed weekly during the RSV season by telephone or email or (daily) telephone app. If a child experiences a new episode of ARTI according to the parents, the study team will visit the child to collect a nasopharyngeal sample, 200µl is used to perform a point of care (POC) test for RSV, and the rest will be stored for additional viral testing by Reverse Transcription-Polymerase Chain Reaction (RT-PCR). If RSV is positive, parents will be asked informed consent to obtain additional blood, nasopharyngeal, urine and stool samples at the time of RSV infection and 6-8 weeks after RSV infection.
Parents of all children in the active cohort will be asked yearly to fill in a questionnaire until age 3 years maximum or till end of study (defined as the moment that the last included subject has been followed up for 12 months).
If parents decline to participate in the active birth cohort, informed consent will be asked for passive follow up. Parents of participants in passive follow-up will be asked to fill in a questionnaire at birth and after one year. If their child was admitted to the hospital because of an ARTI, clinical data will be collected retrospectively from the hospital. Participating hospitals will perform RSV tests as part of standard diagnostic care in children <1 year of age who are admitted with ARTI. Only children with hospitalization due to ARTI will be followed up by a yearly questionnaire until age 3 years maximum or till end of study (defined as the moment that the last included subject has been followed up for 12 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cohort (N=1000) | – | Other: No interventionParticipants in this group will complete questionnaires at baseline (birth) and after 1-2-3 years. At baseline samples will be collected (blood/nasopharyngeal/urine/feces/buccal). During the RSV season(Oct-May) active sampling for RSV will be done when infants experience a respiratory infection. |
| Passive cohort (N=9000) | – | Other: No interventionParents who agree with participation in the study will be asked to fill out a questionnaire at inclusion in the first week(s) after birth and at age one year. Only children who were admitted to the hospital for ARTI during the first year of life will be followed up to the age of maximum 3 years by yearly questionnaires. |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Birth cohort of 10,000 healthy term infants of the general population including a nested (active) cohort of 1,000 healthy term infants. Subjects will be recruited from maternity wards during the first days after birth in the following countries: the Netherlands (UMCU), United Kingdom (UEDIN, UOXF), Spain (Sergas) and Finland (TUH).
Key inclusion criteria (3 listed)
- Healthy* children, gestation age at least 37+0, born at participating centers.
- Written informed consent obtained from parents.
- Parents ability and willingness to adhere to protocol-specified procedures (active cohort).
Key exclusion criteria (11 listed)
- History of clinically significant medical illness including but not limited to, cardiovascular, respiratory, renal, gastrointestinal, haematologic, neurological, endocrine, immunological, musculoskeletal, oncological or congenital disorders, as judged by the investigator. Specifically excluded examples include, but are not limited to:
- Gestational age of less than 37+0 weeks.
- Acute severe medical condition at moment of heel prick (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 |
|---|---|---|
| No interventionNot applicable (no intervention) | Other | Active cohort (N=1000), Passive cohort (N=9000) |
Primary outcome
Number of participants with a Medically attended RSV acute lower respiratory tract infection (MA-RSV-ALRI) based on a positive RT-PCR for RSV who visit a clinician during the RSV-ALRI.
Time frame: In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)
Lower respiratory tract infection proven to be caused by RSV for which medical consultation (general practitioner/specialist/hospitalization) is required. RSV infection is confirmed using RT-PCR from a nasal swab collected by the study team in the active cohort in case of respiratory infection. In the passive cohort, this information is collected from medical data from the hospital in case of hospitalization.
Number of participants with a RSV hospitalization (hospitalization with RT-PCR confirmed RSV).
Time frame: In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)
Hospitalization for a respiratory tract infection proven to be caused by RSV. This information is collected from the hospital data. RSV must be confirmed by RT-PCR.
Number of participants with an RSV infection
Time frame: Active cohort only, during the RSV season (Oct-May)
Incidence of RSV outside of the medical setting (active cohort only). When participants experience respiratory symptoms, the study team plans a visit to perform RSV diagnostics (nasopharyngeal swab).
11 secondary outcomes
RSV-related wheeze incidence
Time frame: The incidence of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for ARTI) maximum or till end of study.
RSV related wheeze sequelae
Time frame: Severity of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for ARTI) maximum or till end of study.
All cause MA-ARTI
Time frame: annual questionnaire at age 1 year (all participants)
Effect of RSV on health care cost
Time frame: Questionnaires during the first year of life (all), and up to 3 years of age (active cohort, RSV+ cases)
Effect of all-cause ARTI on health care cost
Time frame: Questionnaires during the first year of life (all), and up to 3 years of age (active cohort)
RSV related secondary bacterial infections and the use of antibiotics
Time frame: Hospitalization case report form (CRF) (1 year, all participants), active follow-up during the RSV season in the first year of life in the active cohort.
Sample collection for biomarker research (blood, nasal swab, nasopharyngeal swab, urine, faeces, buccal swab)
Time frame: This is collected at baseline (around the 5th day of life) for active participants and in case of an RSV infection during the winter season.
Incidence of other respiratory pathogens
Time frame: Hospitalization CRF (1 year all participants)
Proportion of RSV in viral ARTI
Time frame: active follow-up during the RSV season in the first year of life in the active cohort.
Risk factors for (severe) RSV infection
Time frame: Questionnaires baseline/1 year/hospitalization, for all participants
Effect of RSV on Health-Related Quality of Life (HRQoL)
Time frame: Quality of Life is assessed at baseline, during the RSV season and after 1,2,3 years of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 40343736Hak SF, Venekamp RP, Billard MN, Cianci D, Van Houten MA, Pollard AJ, Heikkinen T, Cunningham S, Millar M, Martinon-Torres F, Dacosta-Urbieta A, Bont LJ, Wildenbeest JG; PROMISE Investigators. Antibiotic use attributable to RSV infections during infancy-an international prospective birth cohort study. J Antimicrob Chemother. 2025 Jul 1;80(7):1803-1812. doi: 10.1093/jac/dkaf123.
- Derived from this study: PubMed 38424744Hak SF, Venekamp RP, Billard MN, van Houten MA, Pollard AJ, Heikkinen T, Cunningham S, Millar M, Martinon-Torres F, Dacosta-Urbieta A, Bont LJ, Wildenbeest JG; PROMISE Investigators. Substantial Burden of Nonmedically Attended RSV Infection in Healthy-Term Infants: An International Prospective Birth Cohort Study. J Infect Dis. 2024 Mar 1;229(1):S40-S50. doi: 10.1093/infdis/jiad477.
- Derived from this study: PubMed 36372082Wildenbeest JG, Billard MN, Zuurbier RP, Korsten K, Langedijk AC, van de Ven PM, Snape MD, Drysdale SB, Pollard AJ, Robinson H, Heikkinen T, Cunningham S, O'Neill T, Rizkalla B, Dacosta-Urbieta A, Martinon-Torres F, van Houten MA, Bont LJ; RESCEU Investigators. The burden of respiratory syncytial virus in healthy term-born infants in Europe: a prospective birth cohort study. Lancet Respir Med. 2023 Apr;11(4):341-353. doi: 10.1016/S2213-2600(22)00414-3. Epub 2022 Nov 10.
- Derived from this study: PubMed 32794574Wildenbeest JG, Zuurbier RP, Korsten K, van Houten MA, Billard MN, Derksen-Lazet N, Snape MD, Drysdale SB, Robinson H, Pollard AJ, Heikkinen T, Cunningham S, Leach A, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Gomez-Carballa A, Bont LJ; RESCEU Investigators. Respiratory Syncytial Virus Consortium in Europe (RESCEU) Birth Cohort Study: Defining the Burden of Infant Respiratory Syncytial Virus Disease in Europe. J Infect Dis. 2020 Oct 7;222(Suppl 7):S606-S612. doi: 10.1093/infdis/jiaa310.
- Derived from this study: PubMed 32702120Lin GL, Golubchik T, Drysdale S, O'Connor D, Jefferies K, Brown A, de Cesare M, Bonsall D, Ansari MA, Aerssens J, Bont L, Openshaw P, Martinon-Torres F, Bowden R, Pollard AJ; RESCEU Investigators. Simultaneous Viral Whole-Genome Sequencing and Differential Expression Profiling in Respiratory Syncytial Virus Infection of Infants. J Infect Dis. 2020 Oct 7;222(Suppl 7):S666-S671. doi: 10.1093/infdis/jiaa448.
- RESCEU websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. During the course of the study, individual participant data (IPD) will only be available for researchers within the consortium.
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Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
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.
Louis Bont, Prof. Dr. principal investigator
University Medical Centre Utrecht (UMCU)
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection and Respiratory Syncytial Virus Infections, run by UMC Utrecht at 5 sites in 4 countries.
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 11 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Finland, Netherlands, Spain. 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?
Results are not available in the source record.
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 participants with a Medically attended RSV acute lower respiratory tract infection (MA-RSV-ALRI) based on a positive RT-PCR for RSV who visit a clinician during the RSV-ALRI. (time frame: In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627572, which also lists 5 linked publications.
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 3 Jun 2021.