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RecruitingNCT06446947EPISEPSISUpdated Feb 12, 2026

Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis

An observational study in Sepsis Syndrome, Septic Shock and Sepsis, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Open to male participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
45 Years to 75 Years
Sex
Male
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Study 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 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.

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Conditions studied

  • Sepsis Syndrome
  • Septic Shock
  • Sepsis
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In context

Systemic Inflammatory Response Syndrome

180 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.

This study's planned enrollment of 25 is below the median of 134 across 88 observational studies indexed under Systemic Inflammatory Response Syndrome.

Browse Systemic Inflammatory Response Syndrome studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male patients admitted to critical care for sepsis after thoracic or chest surgery.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Septic shock

    Patients with sepsis admitted to intensive care who developed septic shock.

    Other: blood sampling

  • No septic shock

    Patients with sepsis admitted to critical care with a favorable outcome (no septic shock)

    Other: blood sampling

Interventions

  • Otherblood sampling

    Blood sampling (6ml) on admission and a second on discharge from intensive care.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

  2. 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

    Time frame: 18 months

  3. 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.

    Time frame: 18 months

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Study locations

1 of 1 sites recruiting
  • Service Anesthésie Réanimation - Hôpital Nord - Assistance Publique Hôpitaux de Marseille
    Marseille, Bouches du Rhône 13015, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06446947
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jun 6, 2024
Start date
Mar 20, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Feb 12, 2026

Study contacts

Marc LEONE, MD PHD
Contact
marc.leone@ap-hm.fr
0491968655
François CREMIEUX
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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