RESCEU: Defining the Burden of RSV Disease

NCT03698084 | Active Not Recruiting DMC

• 1 other identifier: 2017/01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus Infections; RSV Infection

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  Year 1

• 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.

  Year 4

• 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.

  Year 5

• 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.

  Year 6

Secondary Outcomes (11)

• Wheeze symptoms up to 3 years of age following RSV infection of different severity

  Year 1 - 3

• Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).

  Year 1

• RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).

  Year 1 - 3

• Health care costs and resource use

  Year 1 - 3

• 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.

  Within 21 days of RSV infection

Study Arms (2)

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.

Procedure: venepuncture; Procedure: nasopharyngeal swab

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.

Interventions

venepuncture PROCEDURE

sample collection for analysis

Active

nasopharyngeal swab PROCEDURE

sample collection for analysis

Active

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood; transcriptomics, serum, whole blood Nasopharyngeal swabs; PCR, virology, microbiome Stool; microbiome Urine; metabolome

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 5, 2018
• Study Start: September 5, 2017
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

GB (1)