Status:

COMPLETED

Immune Failure in Critical Therapy (INFECT) Study

Lead Sponsor:

University of Edinburgh

Collaborating Sponsors:

Technology Strategy Board, United Kingdom

Becton, Dickinson and Company

Conditions:

Sepsis

Septic Shock

Eligibility:

All Genders

16+ years

Brief Summary

Patients admitted to intensive care units (ICU) are at high risk of developing secondary infections, and this is in part due to dysfunction or failure of their 'germ killing' functions (the immune sys...

Eligibility Criteria

Inclusion

  • Age \>16 (\>18 in England)
  • Requiring level 3 care (i.e. requiring invasive support of respiratory system alone, or two or more other organ systems (haemofiltration, inotropes/vasopressors)
  • Predicted to remain in ICU for at least 48 hours,

Exclusion

  • Not expected to survive for a further 24 hours
  • Known or suspected ICU-acquired infection at time of screening (non-ICU acquired nosocomial infection - i.e. non-ICU healthcare associated infection is NOT and exclusion)
  • Known inborn errors of immune function
  • Immunosuppression (corticosteroids up to 400mg hydrocortisone equivalent daily dose permitted)
  • HIV infection
  • Pregnancy
  • Previously enrolled in the study

Key Trial Info

Start Date :

July 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2016

Estimated Enrollment :

168 Patients enrolled

Trial Details

Trial ID

NCT02186522

Start Date

July 1 2014

End Date

January 1 2016

Last Update

October 26 2016

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom, EH16 4SA

2

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

3

St Thomas' Hospital

London, United Kingdom, SE1 7EH

4

Sunderland Royal Hospital

Sunderland, United Kingdom, SR4 7TP