NCT06446947 Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
| NCT ID | NCT06446947 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Sepsis Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-03-20 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: * 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.
Contact & Investigator
François CREMIEUX
STUDY DIRECTOR
Assistance Publique Hopitaux De Marseille
Frequently Asked Questions
Who can join the NCT06446947 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 75 Years, studying Sepsis Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06446947 currently recruiting?
Yes, NCT06446947 is actively recruiting participants. Contact the research team at marc.leone@ap-hm.fr for enrollment information.
Where is the NCT06446947 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06446947 clinical trial?
NCT06446947 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is François CREMIEUX at Assistance Publique Hopitaux De Marseille. The trial plans to enroll 25 participants.