Immune Failure in Critical Therapy (INFECT) Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis, Septic Shock

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critical Care Patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Outcome (lived/died) |  | Within first 16 days | 
| 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) | 
| Duration of organ support in ICU |  | Within first 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Septic shock, Critical care, Immune dysfunction, Inflammatory markers, Neutrophil, Monocyte, Tregs