Understanding RSV: Severe Disease and the Long Term Consequences

University of Oxford

Status: Active, not recruiting

Conditions: Respiratory Syncytial Virus (RSV)

Treatments: Diagnostic Test: RSV point of care testing

Study type: Observational

Funder types: Other

Identifiers

NCT03756766

OVG 2017/02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 315 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: All of the following must apply

• parent/carer of the infant is willing and able to give informed consent for participation in the study
• Male or female, less than 12 months of age at enrolment
• Parent has a telephone

For group 1 only:

• Hospitalised for <48 hours at enrolment or within 96 hours of onset of illness
• Live near enough to a participating study centre for the 6-8 week home visit

Exclusion Criteria:

• Infants who have received treatment for RSV infection (eg: ribavirin)
• Infants who have had prior exposure to an RSV vaccine or medication
• Infants who have received preventative therapy for RSV (eg; palivizumab)
• Infants who have received oral steroids or montelukast within 7days of enrolment on the study

Trial design

315 participants in 2 patient groups

RSV positive ARTI

Description:

RSV point of care testing will be performed (if result not already available) to confirm RSV positive status. Individuals with confirmed acute respiratory tract infection (ARTI) secondary to RSV (Group 1- active) will have nasopharyngeal swabs, blood samples, urine samples and stool samples taken at the time of recruitment and again at 7 weeks (convalescence). Group 1 participants are categorised into 4 groups as follows: Group 1a and 1b participants are healthy infants with an RSV infection either requiring hospitalisation for at least 12 hours or not requiring hospitalisation respectively. Group 1c \& 1d are infants with an RSV infection with any co-morbidity that would exclude them from Group 1a and 1b either requiring hospitalisation for at least 12 hours or not respectively.

Treatment:

Diagnostic Test: RSV point of care testing

Healthy controls

Description:

This group will include healthy infants (Group 2) who do not have an RSV positive respiratory tract infection and have been asymptomatic in the week preceding and following recruitment. This group will have nasopharyngeal swabs, a blood test and a stool and urine sample taken at enrolment only.