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Immune Failure in Critical Therapy (INFECT) Study (INFECT)

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ClinicalTrials.gov Identifier: NCT02186522
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Technology Strategy Board, United Kingdom
Becton, Dickinson and Company
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date July 7, 2014
First Posted Date July 10, 2014
Last Update Posted Date October 26, 2016
Study Start Date July 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 7, 2014)
The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period. [ Time Frame: Within the first 16 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 7, 2014)
  • ICU Outcome (lived/died) [ Time Frame: Within first 16 days ]
  • Death from sepsis [ Time Frame: Within first 16 days ]
  • Organ dysfunction as determined by SOFA score [ Time Frame: Within first 14 days ]
  • Length of ICU stay [ Time Frame: Up to 3 months (for current hospital admission only) ]
  • Duration of organ support in ICU [ Time Frame: Within first 14 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune Failure in Critical Therapy (INFECT) Study
Official Title Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults
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 system). Our group has recently identified three signatures of immune system failure which can be readily detected on a blood sample, and importantly, appear to predict the chances of developing secondary infection. Such a test would have major benefits for the management of patients in intensive care if it can be translated into a test usable in everyday clinical practice. This study aims to validate our original findings in a cohort of patients from multiple ICUs, using a test which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test.

Study hypothesis:

Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict the risk of nosocomial infection.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Samples of serum and plasma stored frozen
Sampling Method Probability Sample
Study Population Critical Care patients who are expected to remain in ICU for at least 48 hours, and require the external support of one or more organs (invasive ventilation, inotropes/vasopressors or renal replacement therapy) and who are not expected to die within 48 hours of study entry.
Condition
  • Sepsis
  • Septic Shock
Intervention Not Provided
Study Groups/Cohorts Critical Care Patients
Patients staying in the ICU for at least 48 hours, requiring external support of one or more organs (invasive ventilation, inotropes/vasopressors or renal replacement therapy) and who are not expected to die within 48 hours of study entry.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 25, 2016)
168
Original Estimated Enrollment
 (submitted: July 7, 2014)
220
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02186522
Other Study ID Numbers 2014/0208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Edinburgh
Study Sponsor University of Edinburgh
Collaborators
  • Technology Strategy Board, United Kingdom
  • Becton, Dickinson and Company
Investigators
Principal Investigator: Andrew Conway Morris, MD University of Cambridge
Principal Investigator: Tim S Walsh, MD NHS Lothian/University of Edinburgh
Principal Investigator: John Simpson, MD Newcastle University
Principal Investigator: Alistair Roy, MD City Hospitals Sunderland NHS Foundation Trust
Principal Investigator: Alun Brown Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Manu Shankar-Hari, MD Guy's and St Thomas' NHS Foundation Trust
Principal Investigator: Anthony Bateman, MD NHS Lothian (Western General Hospital)
PRS Account University of Edinburgh
Verification Date November 2015