Immune Failure in Critical Therapy (INFECT) Study

Sepsis Clinical Trial

— INFECT  

Official title:

Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186522
• Other study ID #: 2014/0208
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: October 25, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	St Thomas' Hospital	London
United Kingdom	Sunderland Royal Hospital	Sunderland

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Becton, Dickinson and Company, Technology Strategy Board, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period.		Within the first 16 days	No
Secondary	ICU Outcome (lived/died)		Within first 16 days	No
Secondary	Death from sepsis		Within first 16 days	No
Secondary	Organ dysfunction as determined by SOFA score		Within first 14 days	No
Secondary	Length of ICU stay		Up to 3 months (for current hospital admission only)	No
Secondary	Duration of organ support in ICU		Within first 14 days	No