Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

Recruiting

• Conditions: Sepsis; Septic Shock

• Registration Number: NCT06287684
• Lead Sponsor: Mater Dei Hospital, Malta

Brief Summary

Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular subtypes, or subclasses, with clinical implications. Classifying sepsis patients as molecular subtypes revealed that a poor prognosis subtype was characterized by immunosuppression and septic shock. Therefore, it has become essential to identify patients who may benefit from or be adversely affected by specific treatments, thereby identifying bona fide treatable traits or endotypes. The goal of this study is to assist the physician at the bedside in tailoring the treatment of an individual patient suffering from sepsis by generating rapid molecular information about immune status.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-16
• Primary Completion: 2028-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular subtype assignments	Through study completion, an average of 2 year	Molecular subtype classification of sepsis patients using a consensus transcriptomic subtype model
Molecular information about the host response in patients with sepsis	Through study completion, an average of 2 year	Measurement of soluble mediators of host immune responses, including inflammation, coagulation, endothelial function

Secondary Outcome Measures

Name	Time	Method
Survival	3 years	Assessment of survival

Trial Locations

Locations (1)

Mater Dei hospital, Intensive Therapy Unit; 🇲🇹 Imsida, Malta