Immune Failure in Critical Therapy (INFECT) Study

Completed

• Conditions: Septic Shock; Sepsis

• Registration Number: NCT02186522
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Status Verified: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Death from sepsis	Within first 16 days
Organ dysfunction as determined by SOFA score	Within first 14 days
Length of ICU stay	Up to 3 months (for current hospital admission only)
ICU Outcome (lived/died)	Within first 16 days
Duration of organ support in ICU	Within first 14 days

Trial Locations

Locations (4)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Sunderland Royal Hospital; 🇬🇧 Sunderland, United Kingdom

St Thomas' Hospital; 🇬🇧 London, United Kingdom