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NCT Number: NCT02186522

Immune Failure in Critical Therapy (INFECT) Study

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.

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Key information

Conditions

Sepsis Immune System Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh, Edinburgh, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Becton, Dickinson and Company
  • Technology Strategy Board, United Kingdom

Registry information

Official study title

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

Acronym: INFECT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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