Sepsis SyndromeEPISEPSISNCT06446947
Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
An observational study of Sepsis Syndrome and Septic Shock, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between… Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Sepsis Syndrome, Septic Shock, Sepsis
- What is being tested?
- blood sampling
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients admitted to critical care for sepsis after thoracic or chest surgery.
Who may be able to join
- Male patients,
- Patients between 45 and 75 years of age,
- Patients undergoing major esophageal or digestive carcinological surgery,
- Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).
Who cannot join
- patients under 45 and aged 76 and over,
- female patients,
- non-carcinological or minor surgery,
- non-esophageal or non-digestive surgery,
- Gram-positive bacterial or fungal infections in the absence of associated BGN,
- patients with hematological cancer,
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- immunocompromised patients,
- septic surgery (surgical site infection),
- patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study,
- patients under guardianship or curatorship,
- patients not affiliated to a social security system or equivalent in France,
- patients deprived of their liberty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille
Marseille, Bouches du Rhône, 13015
About this study
Official title: Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.
The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.
- Conditions
- Sepsis Syndrome, Septic Shock, Sepsis
- Being tested
- blood sampling
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
Blood sampling (6ml) on admission and a second on discharge from intensive care.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock | Patients with sepsis admitted to intensive care who developed septic shock. Receives: Other: blood sampling | |
| No septic shock | Patients with sepsis admitted to critical care with a favorable outcome (no septic shock) Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify prognostic markers for the progression of sepsis to septic shock
Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.
Measured: 18 months
Secondary outcomes (3)
Epigenetic markers comparaison
Epigenetic markers and associated candidate genes identified in PBMC at the time of sepsis between the group of subjects progressing to septic shock and the group of subjects not progressing to septic shock.
Measured: 18 months
Differentials in epigenetic marks and associated candidate genes
Compare differentials in epigenetic marks and associated candidate genes (sepsis, second sampling) between the group of subjects progressing to septic shock and the group of subjects not progressing to septic shock
Measured: 18 months
Epigenetic marks and associated candidate genes identified in PBMC
In both groups, compare the epigenetic marks and associated candidate genes identified in PBMC during sepsis with those identified in PBMC collected at the time of septic shock or discharge from critical care.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start20 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446947
- Sponsor's protocol ID
- RCAPHM23_0006
- Acronym
- EPISEPSIS
- Status last verified
- Feb 2026
- First submitted
- 29 May 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
- ClinicalTrials.gov ID
- NCT06446947
- Acronym / sponsor ID
- EPISEPSIS / RCAPHM23_0006
- Conditions
- Sepsis Syndrome, Septic Shock, Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Jun 2024 (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.
Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.
The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic shock | – | Other: blood samplingPatients with sepsis admitted to intensive care who developed septic shock. |
| No septic shock | – | Other: blood samplingPatients with sepsis admitted to critical care with a favorable outcome (no septic shock) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients admitted to critical care for sepsis after thoracic or chest surgery.
Key inclusion criteria (4 listed)
- Male patients,
- Patients between 45 and 75 years of age,
- Patients undergoing major esophageal or digestive carcinological surgery,
- Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).
Key exclusion criteria (12 listed)
- patients under 45 and aged 76 and over,
- female patients,
- non-carcinological or minor surgery,
- non-esophageal or non-digestive surgery,
- Gram-positive bacterial or fungal infections in the absence of associated BGN,
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 |
|---|---|---|
| blood samplingBlood sampling (6ml) on admission and a second on discharge from intensive care. | Other | No septic shock, Septic shock |
Primary outcome
Identify prognostic markers for the progression of sepsis to septic shock
Time frame: 18 months
Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.
3 secondary outcomes
Epigenetic markers comparaison
Time frame: 18 months
Differentials in epigenetic marks and associated candidate genes
Time frame: 18 months
Epigenetic marks and associated candidate genes identified in PBMC
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
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 Syndrome and Septic Shock, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Feb 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc LEONE, MD PHD (0491968655, marc.leone@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify prognostic markers for the progression of sepsis to septic shock (time frame: 18 months). 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 12 Feb 2026.