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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease
Sepsis Septic Shock

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Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. ICU Outcome (lived/died) [ Time Frame: Within first 16 days ]
  2. Death from sepsis [ Time Frame: Within first 16 days ]
  3. Organ dysfunction as determined by SOFA score [ Time Frame: Within first 14 days ]
  4. Length of ICU stay [ Time Frame: Up to 3 months (for current hospital admission only) ]
  5. Duration of organ support in ICU [ Time Frame: Within first 14 days ]

Biospecimen Retention:   Samples Without DNA
Samples of serum and plasma stored frozen


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186522


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP
Sponsors and Collaborators
University of Edinburgh
Technology Strategy Board, United Kingdom
Becton, Dickinson and Company
Investigators
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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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02186522    
Other Study ID Numbers: 2014/0208
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: November 2015
Keywords provided by University of Edinburgh:
Sepsis
Septic shock
Critical care
Immune dysfunction
Inflammatory markers
Neutrophil
Monocyte
Tregs
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock