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Understanding RSV: Severe Disease and the Long Term Consequences

NCT03756766 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 315

Last updated 2022-11-22

No results posted yet for this study

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 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.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

DIAGNOSTIC_TEST

RSV point of care testing

Patients will have 2 nasopharyngeal swabs, a nasal swab, a stool and urine taken at baseline/ enrolment and the RSV positive ARTI group will have samples repeated at 6-8weeks.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

  • Innovative Medicines Initiative

    collaborator OTHER

  • Respiratory syncytial virus consortium in Europe

    collaborator UNKNOWN

Principal Investigators

  • Andrew Pollard · Oxford Vaccine Group

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756766 on ClinicalTrials.gov