Status:

COMPLETED

Paediatric Inflammatory Multisystem Syndrome During COVID-19 Pandemic

Lead Sponsor:

Anglia Ruskin University

Conditions:

Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2

Eligibility:

All Genders

3-16 years

Brief Summary

During the COVID-19 pandemic, a small minority of children have been presenting to acute paediatric services with a new syndrome, Paediatric Inflammatory Multisystem Syndrome temporally associated wit...

Detailed Description

During the COVID-19 pandemic a minority of children have presented to acute services with clinical features of a new syndrome known as Paediatric Inflammatory Multisystem Syndrome temporally associate...

Eligibility Criteria

Inclusion

  • Within the age range of 3 months to ≤16 years
  • Presenting clinically to non-ICU paediatric acute services at hospitals in the East of England region with symptoms suggestive of PIMS (e.g. incomplete Kawasaki's disease/Toxic Shock Syndrome) i.e. having: persistent fever (\>38.0oC for 5 or more days) AND high CRP (\>80) AND with one or more of additional features listed in Appendix 1 of the RCPCH document 'Guidance: paediatric multisystem inflammatory syndrome temporarily associated with COVID-19'
  • Having either a positive or negative SARS-Cov-2 PCR test

Exclusion

  • Aged below 3 months old or above 16 years old
  • Confirmation of any microbial cause other than SARS-Cov-2 (including bacterial sepsis, staphylococcal or streptococcal shock syndromes, infections associated with myocarditis such as enterovirus). Determination of such microbial causes is by routine testing i.e. blood culture; pneumococcal, meningococcal, group A strep, staph aureus blood PCR; ASOT; EBV, CMV, adenovirus, enterovirus PCR on blood; urine and stool culture; throat swab culture; stool virology.

Key Trial Info

Start Date :

June 22 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2021

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04761913

Start Date

June 22 2021

End Date

December 31 2021

Last Update

February 9 2022

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Mid Essex Hospital Trust

Chelmsford, Essex, United Kingdom, CM1 7ET

2

East Suffolk and north Essex NHS Foundation Trust

Colchester, Essex, United Kingdom, CO4 5JL

3

The Princess Alexandra Hospital NHS Trust

Harlow, Essex, United Kingdom, CM20 1QX

4

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom, NR31 6LA