SepsisINFECTNCT02186522
Immune Failure in Critical Therapy (INFECT) Study
An observational study of Sepsis and Septic Shock, run by University of Edinburgh at 4 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 168 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Western General Hospital
Edinburgh, EH4 2XU
St Thomas' Hospital
London, SE1 7EH
Sunderland Royal Hospital
Sunderland, SR4 7TP
About this study
Official title: Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults
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.
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, Critical care, Immune dysfunction, Inflammatory markers, Neutrophil, Monocyte, Tregs
- Medical subject headings
- Sepsis, Shock, Septic, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period.
Measured: Within the first 16 days
Secondary outcomes (5)
ICU Outcome (lived/died)
Measured: Within first 16 days
Death from sepsis
Measured: Within first 16 days
Organ dysfunction as determined by SOFA score
Measured: Within first 14 days
Length of ICU stay
Measured: Up to 3 months (for current hospital admission only)
Duration of organ support in ICU
Measured: Within first 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Technology Strategy Board, United Kingdom, Becton, Dickinson and Company
- Responsible party
- Sponsor
- Investigators
- Andrew Conway Morris, MD, Principal investigator, University of CambridgeTim S Walsh, MD, Principal investigator, NHS Lothian/University of EdinburghJohn Simpson, MD, Principal investigator, Newcastle UniversityAlistair Roy, MD, Principal investigator, City Hospitals Sunderland NHS Foundation TrustAlun Brown, Principal investigator, Guy's and St Thomas' NHS Foundation TrustManu Shankar-Hari, MD, Principal investigator, Guy's and St Thomas' NHS Foundation TrustAnthony Bateman, MD, Principal investigator, NHS Lothian (Western General Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186522
- Sponsor's protocol ID
- 2014/0208
- Acronym
- INFECT
- Status last verified
- Nov 2015
- First submitted
- 7 Jul 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Conway Morris A, Datta D, Shankar-Hari M, Stephen J, Weir CJ, Rennie J, Antonelli J, Bateman A, Warner N, Judge K, Keenan J, Wang A, Burpee T, Brown KA, Lewis SM, Mare T, Roy AI, Hulme G, Dimmick I, Rossi AG, Simpson AJ, Walsh TS. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study. Intensive Care Med. 2018 May;44(5):627-635. doi: 10.1007/s00134-018-5247-0. Epub 2018 Jun 7.
PubMed 29915941Conway Morris A, Datta D, Shankar-Hari M, Weir CJ, Rennie J, Antonelli J, Rossi AG, Warner N, Keenan J, Wang A, Brown KA, Lewis S, Mare T, Simpson AJ, Hulme G, Dimmick I, Walsh TS. Predictive value of cell-surface markers in infections in critically ill patients: protocol for an observational study (ImmuNe FailurE in Critical Therapy (INFECT) Study). BMJ Open. 2016 Jul 18;6(7):e011326. doi: 10.1136/bmjopen-2016-011326.
PubMed 27431901
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT02186522
- Acronym / sponsor ID
- INFECT / 2014/0208
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic shock, Critical care, Immune dysfunction, Inflammatory markers, Neutrophil, Monocyte, Tregs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Technology Strategy Board, United Kingdom, Becton, Dickinson and Company
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
ICU Outcome (lived/died)
Time frame: Within first 16 days
Death from sepsis
Time frame: Within first 16 days
Organ dysfunction as determined by SOFA score
Time frame: Within first 14 days
Length of ICU stay
Time frame: Up to 3 months (for current hospital admission only)
Duration of organ support in ICU
Time frame: Within first 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 29915941Conway Morris A, Datta D, Shankar-Hari M, Stephen J, Weir CJ, Rennie J, Antonelli J, Bateman A, Warner N, Judge K, Keenan J, Wang A, Burpee T, Brown KA, Lewis SM, Mare T, Roy AI, Hulme G, Dimmick I, Rossi AG, Simpson AJ, Walsh TS. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study. Intensive Care Med. 2018 May;44(5):627-635. doi: 10.1007/s00134-018-5247-0. Epub 2018 Jun 7.
- Derived from this study: PubMed 27431901Conway Morris A, Datta D, Shankar-Hari M, Weir CJ, Rennie J, Antonelli J, Rossi AG, Warner N, Keenan J, Wang A, Brown KA, Lewis S, Mare T, Simpson AJ, Hulme G, Dimmick I, Walsh TS. Predictive value of cell-surface markers in infections in critically ill patients: protocol for an observational study (ImmuNe FailurE in Critical Therapy (INFECT) Study). BMJ Open. 2016 Jul 18;6(7):e011326. doi: 10.1136/bmjopen-2016-011326.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Conway Morris, MD principal investigator
University of Cambridge
Tim S Walsh, MD principal investigator
NHS Lothian/University of Edinburgh
John Simpson, MD principal investigator
Newcastle University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by University of Edinburgh at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186522, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.