RESCEU: Defining the Burden of RSV Disease

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 19, 2017

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 5, 2017

Estimated Primary Completion Date

August 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Wheeze symptoms up to 3 years of age following RSV infection of different severity[ Time Frame: Year 1 - 3 ]
Parent reported wheeze and doctor diagnosis of wheeze by routine care (for active birth cohort and children of passive birth cohort admitted for ARTI).
Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).[ Time Frame: Year 1 ]
Medically attended ARTI is defined as any medical care for a respiratory infection
RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).[ Time Frame: Year 1 - 3 ]
Mortality through all RSV seasons of follow up including RSV-associated deaths and all cause deaths.
Health care costs and resource use[ Time Frame: Year 1 - 3 ]
Health care utilisation for RSV-associated and all-cause medically attended (inpatient or outpatient) ARTI or respiratory events (active birth cohort).
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 ]
The incidence of RSV-associated secondary bacterial pneumonia and associated antibiotic consumption events within 21 days after onset of RSV-related symptoms.
To collect clinical samples (blood, nasopharyngeal, stool and urine) for biomarker analysis (active cohort).[ Time Frame: Year 1 ]
Biomarkers associated with RSV infection in infants
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 ]
Additional viruses as detected by PCR testing on nasopharyngeal swab. Medically attended ARTI is defined as any medical care for a respiratory infection.
Risk factors for RSV infection (by severity and healthcare utilisation) (active and passive cohort).[ Time Frame: Year 1 - 3 ]
Demographic risks factors as outlined in CRF/demographic questionnaires
The proportion of viral ARTI attributable to RSV (active cohort).[ Time Frame: Year 1 ]
RSV and additional viruses as determined by PCR testing of nasopharyngeal swabs
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 ]
Annual questionnaire to families to determine interruption of normal activities associated with RSV and all-cause medically attended ARTI (active cohort).

Descriptive Information

Brief Title ^ICMJE

RESCEU: Defining the Burden of RSV Disease

Official Title ^ICMJE

REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Respiratory Syncytial Virus (RSV) Disease.

Brief Summary

This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 3 years from September 2017 to September 2020. 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. 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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Procedure: venepuncture
sample collection for analysis
Procedure: nasopharyngeal swab
sample collection for analysis

Study Arms

: 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.
: 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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 2020

Estimated Primary Completion Date

August 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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