SepsisEPICETUSNCT05922371
ObsErvational Study of the Practical Cinical UTility of the NuQ.® H3.1 Nucleosome Levels in Adult Patients With Sepsis to Facilitate Early Diagnosis and Prognostication. (EPICETUS)
An observational study of Sepsis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- NuQ H3.1 Nucleosome Assay
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2023to 4 Jul 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The participants will be recruited into two cohorts. The first cohort are patients who require critical care admission emergently from either A\&E or other hospital ward with a presumed diagnosis of sepsis. The second group consists of patients who have a planned elective cardiac surgery (Coronary Artery By-Pass Graft surgery) and require critical care admission post operatively as part of the planned surgery. These patients have been selected to describe how the level of NuQ.® H3.1 alters over time after the sterile insult of cardiac surgery.
Who may be able to join
- Patients must be at least 18 years of age to be included in the study.
- Patients must have been admitted to critical care emergently with signs and symptoms consistent with a possible diagnosis of sepsis: defined as one of these types of infections: respiratory system, renal and genito-urinary system, gastrointestinal and intra-abdominal system, central nervous system, musculoskeletal, sepsis or fever of unknown origin
- A 'comparator' arm will be included of patients aged over 18yrs of age undergoing planned elective coronary artery bypass graft surgery with anticipated post-operative care in critical care unit
Who cannot join
- Any subject not meeting the criteria above.
- Patients who are re-admitted to intensive care unit within the same hospital admission
- The exclusion criteria are designed to remove confounding effects from concomitant conditions that may render the interpretation of the NuQ.® H3.1 assay impossible. These circumstances are few, but exclusions will include patients with limitations of care, including 'Do not attempt resuscitation' orders.
- Patients with severe anaemia (as defined by a Hb<50g/dL) will be excluded.
- Subjects with any other severe concurrent disease that, in the judgment of the Principal Investigator, would make the subject inappropriate for entry into this study.
- Patients in the 'comparator' arm who are undergoing cardiac surgery will be excluded if they have an active infection and specifically patients with a suspected or confirmed diagnosis of infective endocarditis.
- Any patient undergoing cardiac surgery with a condition that might influence their immune response will be excluded. These include but are not limited to uncontrolled HIV, AIDS, uncontrolled systemic lupus erythematosus, rheumatoid arthritis or mixed connective tissue disorder, previous cancer and previous treatment with chemotherapy or the recipient of a solid organ or bone marrow transplant.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London, London, SE1 9RT
About this study
This is a study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. These patients will be compared to a group of adult surgical patients free from infection that are undergoing their first cardiac surgery.
Read the detailed description
This is a single centre, prosepctive study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. The H3.1 assay is a chemiluminescent sandwich immunoassay for the detection of nucleosomes circulating in human plasma. The test quantifies the level of circulating nucleosomes and in conjunction with other laboratory findings and clinical assessment aids in the early detection of sepsis with organ dysfunction.
- Conditions
- Sepsis
- Being tested
- NuQ H3.1 Nucleosome Assay
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuQ H3.1 Nucleosome AssayDiagnostic test
Serial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Adult patients admitted to critical care with a presumed diagnosis of sepsis. Receives: Diagnostic Test: NuQ H3.1 Nucleosome Assay | |
| Cardiac surgery | Adult cardiac surgery patients that are free from infection undergoing their first cardiac surgery. Receives: Diagnostic Test: NuQ H3.1 Nucleosome Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis.
To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis or septic shock (as defined by Sepsis-3 criteria at time of presentation), specifically to monitor how these levels change over time in relation to disease progression, clinical data and other routinely collected biomarkers such as CRP and procalcitonin.
Measured: 14 days
Secondary outcomes (1)
To investigate the potential utility of levels of NETs/Cf DNA (as measured by the H3.1 nucleosome assay) as a companion diagnostic test of septic shock, disease monitoring, severity and prognosis.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start18 Dec 2023
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Volition Diagnostics UK Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922371
- Sponsor's protocol ID
- 324730
- Acronym
- EPICETUS
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ObsErvational Study of the Practical Cinical UTility of the NuQ.® H3.1 Nucleosome Levels in Adult Patients With Sepsis to Facilitate Early Diagnosis and Prognostication. (EPICETUS)
- ClinicalTrials.gov ID
- NCT05922371
- Acronym / sponsor ID
- EPICETUS / 324730
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Volition Diagnostics UK Ltd
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 28 Jun 2023 (actual)
- 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.
This is a study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. These patients will be compared to a group of adult surgical patients free from infection that are undergoing their first cardiac surgery.
Detailed description
This is a single centre, prosepctive study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. The H3.1 assay is a chemiluminescent sandwich immunoassay for the detection of nucleosomes circulating in human plasma. The test quantifies the level of circulating nucleosomes and in conjunction with other laboratory findings and clinical assessment aids in the early detection of sepsis with organ dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Diagnostic Test: NuQ H3.1 Nucleosome AssayAdult patients admitted to critical care with a presumed diagnosis of sepsis. |
| Cardiac surgery | – | Diagnostic Test: NuQ H3.1 Nucleosome AssayAdult cardiac surgery patients that are free from infection undergoing their first cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited into two cohorts. The first cohort are patients who require critical care admission emergently from either A\&E or other hospital ward with a presumed diagnosis of sepsis. The second group consists of patients who have a planned elective cardiac surgery (Coronary Artery By-Pass Graft surgery) and require critical care admission post operatively as part of the planned surgery. These patients have been selected to describe how the level of NuQ.® H3.1 alters over time after the sterile insult of cardiac surgery.
Key inclusion criteria (3 listed)
- Patients must be at least 18 years of age to be included in the study.
- Patients must have been admitted to critical care emergently with signs and symptoms consistent with a possible diagnosis of sepsis: defined as one of these types of infections: respiratory system, renal and genito-urinary system, gastrointestinal and intra-abdominal system, central nervous system, musculoskeletal, sepsis or fever of unknown origin
- A 'comparator' arm will be included of patients aged over 18yrs of age undergoing planned elective coronary artery bypass graft surgery with anticipated post-operative care in critical care unit
Key exclusion criteria (7 listed)
- Any subject not meeting the criteria above.
- Patients who are re-admitted to intensive care unit within the same hospital admission
- The exclusion criteria are designed to remove confounding effects from concomitant conditions that may render the interpretation of the NuQ.® H3.1 assay impossible. These circumstances are few, but exclusions will include patients with limitations of care, including 'Do not attempt resuscitation' orders.
- Patients with severe anaemia (as defined by a Hb<50g/dL) will be excluded.
- Subjects with any other severe concurrent disease that, in the judgment of the Principal Investigator, would make the subject inappropriate for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuQ H3.1 Nucleosome AssaySerial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge. | Diagnostic test | Cardiac surgery, Sepsis |
Primary outcome
To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis.
Time frame: 14 days
To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis or septic shock (as defined by Sepsis-3 criteria at time of presentation), specifically to monitor how these levels change over time in relation to disease progression, clinical data and other routinely collected biomarkers such as CRP and procalcitonin.
1 secondary outcome
To investigate the potential utility of levels of NETs/Cf DNA (as measured by the H3.1 nucleosome assay) as a companion diagnostic test of septic shock, disease monitoring, severity and prognosis.
Time frame: 90 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 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.