Clinical trial NCT03698084: RESCEU: Defining the Burden of RSV Disease
Official title: REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Respiratory Syncytial Virus (RSV) Disease.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiratory Syncytial Virus Infections
RSV Infection
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 2000
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children, gestation age at least 37+0 weeks, born at participating centres and recruited within the first week of life.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
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.
timeFrame: Year 1
measure: The relationship between infant RSV infection of different severity and school age asthma
timeFrame: Year 4
measure: The relationship between infant RSV infection of different severity and school age asthma
timeFrame: Year 5
measure: The relationship between infant RSV infection of different severity and school age asthma
timeFrame: Year 6
Secondary outcomes:
measure: Wheeze symptoms up to 3 years of age following RSV infection of different severity
timeFrame: Year 1 - 3
measure: Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).
timeFrame: Year 1
measure: RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).
timeFrame: Year 1 - 3
measure: Health care costs and resource use
timeFrame: Year 1 - 3
measure: 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.
timeFrame: Within 21 days of RSV infection
measure: To collect clinical samples (blood, nasopharyngeal, stool and urine) for biomarker analysis (active cohort).
timeFrame: Year 1
measure: Incidence rate of other respiratory pathogens (influenza, rhinovirus, human metapneumovirus, parainfluenzavirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI (active cohort).
timeFrame: Year 1
measure: Risk factors for RSV infection (by severity and healthcare utilisation) (active and passive cohort).
timeFrame: Year 1 - 3
measure: The proportion of viral ARTI attributable to RSV (active cohort).
timeFrame: Year 1
measure: Health Related Quality of Life in RSV-associated and all-cause medically attended ARTI patients and their families (active cohort).
timeFrame: Year 1-3
measure: Risk factors for persistent wheeze at 3 and 6 years of age
timeFrame: Year 4,5 and 6
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
References: