Status:
ACTIVE_NOT_RECRUITING
Understanding RSV: Severe Disease and the Long Term Consequences
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Innovative Medicines Initiative
Respiratory syncytial virus consortium in Europe
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
Up to 12 years
Brief Summary
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT03756766
Start Date
December 19 2017
End Date
November 1 2026
Last Update
November 22 2022
Active Locations (2)
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1
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
2
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, United Kingdom