NCT Number: NCT03756766
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.
This study is active but is not currently recruiting participants.
Notify MeUp to 12 month
All sexes
Observational
Oxford University Hospitals NHS Trust, Oxford, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All of the following must apply
For group 1 only:
Exclusion criteria
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.
Other names: Venepuncture, Nasopharyngeal swabs, stool sample, Urine sample
Time frame: 8 weeks
Analysis of blood to determine cellular expression of RNA during a severe, acute RSV respiratory tract infection
Time frame: 8 weeks
Analysis of blood samples to determine how cellular protein concentrations change in response to severe RSV infection
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
Time frame: Year 6
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Time frame: 3 years
Analysis of blood samples will determine changes in cellular RNA associated with RSV infection.
Time frame: 3 years
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
Time frame: 3 years
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.
Time frame: 3 years
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
Time frame: 8 weeks
Nasopharyngeal swabs will be taken at baseline and at 6-8weeks to measure viral load
Time frame: 8 weeks
Nasopharyngeal samples will be taken at baseline and at 6-8weeks do determine the genetic sequencing of the Respiratory Syncytial Virus.
Time frame: 8 weeks
Whole blood will be used for flow cytometric cell phenotyping to determine which immune cells are activated in response to RSV
Time frame: 8 weeks
Whole blood will be used to perform intracellular cytokine staining in response to RSV infection
Time frame: 8 weeks
Blood sampling to determine epigenetic changes associated with RSV infection
Time frame: 8 weeks
This is determined using a standardized respiratory clinical severity score (ReSVinet) which is performed at baseline.
This score has 7 subscales;
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: Year 4
Parental questionnaires and participant medical records
Time frame: Year 5
Parental questionnaires and participant medical records
Time frame: Year 6
Parental questionnaires and participant medical records
Time frame: Year 4
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
Time frame: Year 5
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
Time frame: Year 6
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
University of Oxford
Other
REspiratory Syncytial Virus Consortium in EUrope (RESCEU):Presumed Risk Factors and Biomarkers for RSV-related Severe Disease and Related Sequelae
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