Respiratory Syncytial Virus (RSV)NCT03756766
Understanding RSV: Severe Disease and the Long Term Consequences
An observational study of Respiratory Syncytial Virus (RSV), run by University of Oxford at 2 sites in United Kingdom.
Trial summary
The study design is a case-control, sample based study. 275 cases (Group 1), infants <12 months old with RSV infection and 40 controls (Group 2), otherwise healthy infants <12 months old without RSV infection will be recruited. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSV point of care testing
- How many people
- 315 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Dec 2017to 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
- Healthy volunteers accepted
- Child
Study population: Infants less than 12 months old who present to their GP of to hospital with RSV positive respiratory disease.
Who may be able to join
- parent/carer of the infant is willing and able to give informed consent for participation in the study
- Male or female, less than 12 months of age at enrolment
- Parent has a telephone
- For group 1 only:
- Hospitalised for <48 hours at enrolment or within 96 hours of onset of illness
- Live near enough to a participating study centre for the 6-8 week home visit
Who cannot join
- Infants who have received treatment for RSV infection (eg: ribavirin)
- Infants who have had prior exposure to an RSV vaccine or medication
- Infants who have received preventative therapy for RSV (eg; palivizumab)
- Infants who have received oral steroids or montelukast within 7days of enrolment on the study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Oxford University Hospitals NHS Trust
Oxford
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Oxford
About this study
Official title: REspiratory Syncytial Virus Consortium in EUrope (RESCEU):Presumed Risk Factors and Biomarkers for RSV-related Severe Disease and Related Sequelae
The study design is a case-control, sample based study. 275 cases (Group 1), infants <12 months old with RSV infection and 40 controls (Group 2), otherwise healthy infants <12 months old without RSV infection will be recruited. Samples will be taken on enrolment and for infants in Group 1; repeated at 7 weeks convalescence. There will be annual follow up by questionnaire for up to 6 years and a minimum of 1 year, depending at what stage in the study the infant is enrolled.
Read the detailed description
Human respiratory syncytial virus (RSV) causes severe disease in the very young, elderly and in high risk groups. Worldwide in 2005 there were an estimated 34 million cases of acute lower respiratory tract infection (ALRI), 3.4 million ALRI hospitalisations and 55,000 to 199,000 deaths associated with RSV in children <5 years old. RSV infection in childhood is associated with subsequent wheezing and asthma. These long-term sequelae pose a substantial additional burden on healthcare systems. There is a parallel need to assemble clinical resources to identify the correlates of severe RSV disease for clinical management, classification of disease severity in clinical trials and identification of biomarkers for severe disease, which are currently lacking.
Group 1: Infants under 12 months with an RSV infection will have nasopharyngeal swabs, blood, urine and stool samples taken at the onset of infection and again 6 - 8 weeks later, in convalescence. An online diary will be completed for 2 weeks during illness to record the participant and parent health. The participant and their family will be followed up annually by questionnaire, for a maximum of 6 years. When the study data are analysed, the infants will be subdivided into 4 further groups; healthy infants requiring hospitalisation, healthy infants not requiring hospitalisation, infants with co-morbidity, requiring hospitalisation and infants with a co-morbidity not requiring hospitalisation. Group 2: Well, healthy infants, under 12 months with no acute respiratory infection will have nasopharyngeal swab,blood, urine and stool samples taken on enrolment. They will receive a follow up contact 7 days after enrolment to assess if they have developed any illness. The participant and their family will be followed up annually by questionnaire, for a maximum of 6 years.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSV point of care testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV point of care testingDiagnostic test
Also called Venepuncture, Nasopharyngeal swabs, stool sample, Urine sample
Patients will have 2 nasopharyngeal swabs, a nasal swab, a stool and urine taken at baseline/ enrolment and the RSV positive ARTI group will have samples repeated at 6-8weeks.
| Study group | Role | What they receive |
|---|---|---|
| RSV positive ARTI | RSV point of care testing will be performed (if result not already available) to confirm RSV positive status. Individuals with confirmed acute respiratory tract infection (ARTI) secondary to RSV (Group 1- active) will have nasopharyngeal swabs, blood samples, urine samples and stool samples taken at the time of recruitment and again at 7 weeks (convalescence).
Group 1 participants are categorised into 4 groups as follows:
Group 1a and 1b participants are healthy infants with an RSV infection either requiring hospitalisation for at least 12 hours or not requiring hospitalisation respectively.
Group 1c \& 1d are infants with an RSV infection with any co-morbidity that would exclude them from Group 1a and 1b either requiring hospitalisation for at least 12 hours or not respectively. Receives: Diagnostic Test: RSV point of care testing | |
| Healthy controls | This group will include healthy infants (Group 2) who do not have an RSV positive respiratory tract infection and have been asymptomatic in the week preceding and following recruitment. This group will have nasopharyngeal swabs, a blood test and a stool and urine sample taken at enrolment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ribonucleic acid (RNA) transcripts (Transcriptomics) that are up and down regulated in severe RSV infection
Analysis of blood to determine cellular expression of RNA during a severe, acute RSV respiratory tract infection
Measured: 8 weeks
Cellular protein concentration changes (proteomics) in response to severe RSV infection
Analysis of blood samples to determine how cellular protein concentrations change in response to severe RSV infection
Measured: 8 weeks
Cellular metabolite concentration changes associated with severe RSV disease
Analysis of urine and blood to identify which metabolic pathways are up-regulated at a cellular level following severe RSV infection. This is determined by measuring metabolic by-products
Measured: 8 weeks
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 (18)
Ribonucleic acid (RNA) transcripts that are up or down regulated and contribute to respiratory sequelae following RSV infection in infants
Analysis of blood samples will determine changes in cellular RNA associated with RSV infection.
Measured: 3 years
Cellular protein concentration changes (Proteomics) affecting respiratory sequelae following RSV infection in infants
Analysis of blood to determine how cellular protein production is up or down regulated in response to RSV infection to correlate with subsequent respiratory sequelae
Measured: 3 years
Cellular metabolite concentration changes that contribute to respiratory sequelae following RSV infection
Analysis of blood and urine to determine which cellular metabolites are produced in increasing quantities during RSV infection and which are subsequently responsible for respiratory sequelae.
Measured: 3 years
Respiratory sequelae following RSV infection in infants
Respiratory sequelae in participants will be determined by completion of a baseline questionnaire followed by an annual questionnaire for a maximum of 3 years.
The questionnaires record patient demographics, number of siblings, family history of atopy, exposure to household smoke and pets and the ability of the child and family members to complete their usual activities
Measured: 3 years
Viral load associated with mild and severe RSV disease
Nasopharyngeal swabs will be taken at baseline and at 6-8weeks to measure viral load
Measured: 8 weeks
Genetic sequence of RSV associated with mild and severe disease
Nasopharyngeal samples will be taken at baseline and at 6-8weeks do determine the genetic sequencing of the Respiratory Syncytial Virus.
Measured: 8 weeks
Cellular immune response during RSV infection
Whole blood will be used for flow cytometric cell phenotyping to determine which immune cells are activated in response to RSV
Measured: 8 weeks
Cytokine release associated with severe RSV disease
Whole blood will be used to perform intracellular cytokine staining in response to RSV infection
Measured: 8 weeks
Altered gene expression associated with severe RSV disease
Blood sampling to determine epigenetic changes associated with RSV infection
Measured: 8 weeks
RSV disease severity
This is determined using a standardized respiratory clinical severity score (ReSVinet) which is performed at baseline.
This score has 7 subscales;
- Feeding intolerance (Score 0-3)
- Medical intervention (score 0-3)
- Respiratory difficulty (score 0-3)
- Respiratory frequency (score 0-3)
- Presence of apnoea (either 0, or 3)
- General condition (score 0-3)
- fever (0-2) The total score is determined by adding each component part. The total score is from 0-20. A score of 0 reflects very mild disease whilst a score of 20 indicates severe disease
Measured: 8 weeks
Health care costs and resource use
This will be determined using annual questionnaires sent to participants. The questions include: visits to healthcare providers (hospital, GP), number of admissions and duration where applicable and medication use.
Measured: 3 years
Interruption to normal activities associated with RSV disease
Baseline parental questionnaire followed by 14 day symptom diary at onset of illness. Subsequent annual questionnaire for total of 3 years to determine subsequent disease sequelae.
These questionnaires record symptom severity, duration of symptoms, whether the symptoms affect activities of daily living and a record of persisting symptoms. The follow up questionnaires will extract information about subsequent respiratory symptoms (cough, wheeze), whether the participant has required subsequent review by a healthcare practitioner or been admitted to hospital and during of admission. It also records the need for ongoing medications.
The information extracted is qualitative in nature. There is no scale used for recording this information.
Measured: 3 years
Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections
Parental questionnaires and participant medical records
Measured: Year 4
Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections
Parental questionnaires and participant medical records
Measured: Year 5
Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections
Parental questionnaires and participant medical records
Measured: Year 6
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
Risk factors for persistent wheeze at 3 and 6 years of age
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
Measured: Year 5
Risk factors for persistent wheeze at 3 and 6 years of age
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
Measured: Year 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start19 Dec 2017
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus (RSV)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative, Respiratory syncytial virus consortium in Europe
- Responsible party
- Sponsor
- Investigators
- Andrew Pollard, Study chair, Oxford Vaccine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756766
- Sponsor's protocol ID
- OVG 2017/02
- Status last verified
- Jan 2022
- First submitted
- 4 Oct 2018
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data sets will be shared with other researchers within the RESCEU consortium. These data sets will include information from participants baseline and annual questionnaires and results from bloods, respiratory samples, urine and stool specimens taken at onset of RSV illness and at 6-8 weeks convalescence.
Publications
McGinley JP, Lin GL, Oner D, Golubchik T, O'Connor D, Snape MD, Gruselle O, Langedijk AC, Wildenbeest J, Openshaw P, Nair H, Aerssens J, Bont L, Martinon-Torres F, Drysdale SB, Pollard AJ; RESCEU Investigators. Clinical and Viral Factors Associated With Disease Severity and Subsequent Wheezing in Infants With Respiratory Syncytial Virus Infection. J Infect Dis. 2022 Aug 12;226(Suppl 1):S45-S54. doi: 10.1093/infdis/jiac163.
PubMed 35902389Jefferies K, Drysdale SB, Robinson H, Clutterbuck EA, Blackwell L, McGinley J, Lin GL, Galal U, Nair H, Aerssens J, Oner D, Langedijk A, Bont L, Wildenbeest JG, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Nadel S, Openshaw P, Thwaites R, Widjojoatmodjo M, Zhang L, Nguyen TL, Giaquinto C, Giordano G, Baraldi E, Pollard AJ; RESCEU Investigators. Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU). J Infect Dis. 2020 Oct 7;222(Suppl 7):S658-S665. doi: 10.1093/infdis/jiaa239.
PubMed 32794560Lin 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REspiratory Syncytial Virus Consortium in EUrope (RESCEU):Presumed Risk Factors and Biomarkers for RSV-related Severe Disease and Related Sequelae
- ClinicalTrials.gov ID
- NCT03756766
- Acronym / sponsor ID
- OVG 2017/02
- Conditions
- Respiratory Syncytial Virus (RSV)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative, Respiratory syncytial virus consortium in Europe
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Nov 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 study design is a case-control, sample based study. 275 cases (Group 1), infants <12 months old with RSV infection and 40 controls (Group 2), otherwise healthy infants <12 months old without RSV infection will be recruited. Samples will be taken on enrolment and for infants in Group 1; repeated at 7 weeks convalescence. There will be annual follow up by questionnaire for up to 6 years and a minimum of 1 year, depending at what stage in the study the infant is enrolled.
Detailed description
Human respiratory syncytial virus (RSV) causes severe disease in the very young, elderly and in high risk groups. Worldwide in 2005 there were an estimated 34 million cases of acute lower respiratory tract infection (ALRI), 3.4 million ALRI hospitalisations and 55,000 to 199,000 deaths associated with RSV in children <5 years old. RSV infection in childhood is associated with subsequent wheezing and asthma. These long-term sequelae pose a substantial additional burden on healthcare systems. There is a parallel need to assemble clinical resources to identify the correlates of severe RSV disease for clinical management, classification of disease severity in clinical trials and identification of biomarkers for severe disease, which are currently lacking.
Group 1: Infants under 12 months with an RSV infection will have nasopharyngeal swabs, blood, urine and stool samples taken at the onset of infection and again 6 - 8 weeks later, in convalescence. An online diary will be completed for 2 weeks during illness to record the participant and parent health. The participant and their family will be followed up annually by questionnaire, for a maximum of 6 years. When the study data are analysed, the infants will be subdivided into 4 further groups; healthy infants requiring hospitalisation, healthy infants not requiring hospitalisation, infants with co-morbidity, requiring hospitalisation and infants with a co-morbidity not requiring hospitalisation. Group 2: Well, healthy infants, under 12 months with no acute respiratory infection will have nasopharyngeal swab,blood, urine and stool samples taken on enrolment. They will receive a follow up contact 7 days after enrolment to assess if they have developed any illness. The participant and their family will be followed up annually by questionnaire, for a maximum of 6 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSV positive ARTI | – | Diagnostic Test: RSV point of care testingRSV point of care testing will be performed (if result not already available) to confirm RSV positive status. Individuals with confirmed acute respiratory tract infection (ARTI) secondary to RSV (Group 1- active) will have nasopharyngeal swabs, blood samples, urine samples and stool samples taken at the time of recruitment and again at 7 weeks (convalescence). Group 1 participants are categorised into 4 groups as follows: Group 1a and 1b participants are healthy infants with an RSV infection either requiring hospitalisation for at least 12 hours or not requiring hospitalisation respectively. Group 1c \& 1d are infants with an RSV infection with any co-morbidity that would exclude them from Group 1a and 1b either requiring hospitalisation for at least 12 hours or not respectively. |
| Healthy controls | – | –This group will include healthy infants (Group 2) who do not have an RSV positive respiratory tract infection and have been asymptomatic in the week preceding and following recruitment. This group will have nasopharyngeal swabs, a blood test and a stool and urine sample taken at enrolment only. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants less than 12 months old who present to their GP of to hospital with RSV positive respiratory disease.
Key inclusion criteria (6 listed)
- parent/carer of the infant is willing and able to give informed consent for participation in the study
- Male or female, less than 12 months of age at enrolment
- Parent has a telephone
- Hospitalised for <48 hours at enrolment or within 96 hours of onset of illness
- Live near enough to a participating study centre for the 6-8 week home visit
Key exclusion criteria (4 listed)
- Infants who have received treatment for RSV infection (eg: ribavirin)
- Infants who have had prior exposure to an RSV vaccine or medication
- Infants who have received preventative therapy for RSV (eg; palivizumab)
- Infants who have received oral steroids or montelukast within 7days of enrolment on the study
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 |
|---|---|---|
| RSV point of care testingAlso: Venepuncture, Nasopharyngeal swabs, stool sample, Urine samplePatients will have 2 nasopharyngeal swabs, a nasal swab, a stool and urine taken at baseline/ enrolment and the RSV positive ARTI group will have samples repeated at 6-8weeks. | Diagnostic test | RSV positive ARTI |
Primary outcome
Ribonucleic acid (RNA) transcripts (Transcriptomics) that are up and down regulated in severe RSV infection
Time frame: 8 weeks
Analysis of blood to determine cellular expression of RNA during a severe, acute RSV respiratory tract infection
Cellular protein concentration changes (proteomics) in response to severe RSV infection
Time frame: 8 weeks
Analysis of blood samples to determine how cellular protein concentrations change in response to severe RSV infection
Cellular metabolite concentration changes associated with severe RSV disease
Time frame: 8 weeks
Analysis of urine and blood to identify which metabolic pathways are up-regulated at a cellular level following severe RSV infection. This is determined by measuring metabolic by-products
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.
18 secondary outcomes
Ribonucleic acid (RNA) transcripts that are up or down regulated and contribute to respiratory sequelae following RSV infection in infants
Time frame: 3 years
Cellular protein concentration changes (Proteomics) affecting respiratory sequelae following RSV infection in infants
Time frame: 3 years
Cellular metabolite concentration changes that contribute to respiratory sequelae following RSV infection
Time frame: 3 years
Respiratory sequelae following RSV infection in infants
Time frame: 3 years
Viral load associated with mild and severe RSV disease
Time frame: 8 weeks
Genetic sequence of RSV associated with mild and severe disease
Time frame: 8 weeks
Cellular immune response during RSV infection
Time frame: 8 weeks
Cytokine release associated with severe RSV disease
Time frame: 8 weeks
Altered gene expression associated with severe RSV disease
Time frame: 8 weeks
RSV disease severity
Time frame: 8 weeks
Health care costs and resource use
Time frame: 3 years
Interruption to normal activities associated with RSV disease
Time frame: 3 years
Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections
Time frame: Year 4
Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections
Time frame: Year 5
Compare the incidence of asthma after RSV hospitalisation with incidence of asthma following hospitalisation for viral infections
Time frame: Year 6
Risk factors for persistent wheeze at 3 and 6 years of age
Time frame: Year 4
Risk factors for persistent wheeze at 3 and 6 years of age
Time frame: Year 5
Risk factors for persistent wheeze at 3 and 6 years of age
Time frame: Year 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 22 Nov 2022.
- Derived from this study: PubMed 35902389McGinley JP, Lin GL, Oner D, Golubchik T, O'Connor D, Snape MD, Gruselle O, Langedijk AC, Wildenbeest J, Openshaw P, Nair H, Aerssens J, Bont L, Martinon-Torres F, Drysdale SB, Pollard AJ; RESCEU Investigators. Clinical and Viral Factors Associated With Disease Severity and Subsequent Wheezing in Infants With Respiratory Syncytial Virus Infection. J Infect Dis. 2022 Aug 12;226(Suppl 1):S45-S54. doi: 10.1093/infdis/jiac163.
- Derived from this study: PubMed 32794560Jefferies K, Drysdale SB, Robinson H, Clutterbuck EA, Blackwell L, McGinley J, Lin GL, Galal U, Nair H, Aerssens J, Oner D, Langedijk A, Bont L, Wildenbeest JG, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Nadel S, Openshaw P, Thwaites R, Widjojoatmodjo M, Zhang L, Nguyen TL, Giaquinto C, Giordano G, Baraldi E, Pollard AJ; RESCEU Investigators. Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU). J Infect Dis. 2020 Oct 7;222(Suppl 7):S658-S665. doi: 10.1093/infdis/jiaa239.
- 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 website (coordinators of the Understanding RSV study)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data sets will be shared with other researchers within the RESCEU consortium. These data sets will include information from participants baseline and annual questionnaires and results from bloods, respiratory samples, urine and stool specimens taken at onset of RSV illness and at 6-8 weeks convalescence.
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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.
Andrew Pollard study chair
Oxford Vaccine Group
2 sites 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 (RSV), run by University of Oxford at 2 sites 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 6 inclusion and 4 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 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Ribonucleic acid (RNA) transcripts (Transcriptomics) that are up and down regulated in severe RSV infection (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT03756766, which also lists 3 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 22 Nov 2022.