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Active, Not Recruiting

NCT Number: NCT03698084

RESCEU: Defining the Burden of RSV Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections RSV Infection Virus Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Venepuncture

Procedure

sample collection for analysis

Nasopharyngeal swab

Procedure

sample collection for analysis

Primary outcomes

  1. 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)

  2. The relationship between infant RSV infection of different severity and school age asthma

    Time frame: Year 4

    Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.

  3. The relationship between infant RSV infection of different severity and school age asthma

    Time frame: Year 5

    Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.

  4. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

  4. 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).

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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).

  11. Risk factors for persistent wheeze at 3 and 6 years of age

    Time frame: Year 4,5 and 6

    Demographic and clinical parameters and outcomes from CRF/demographic questionnaires

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2018
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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