Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis (MENDSEP)

Mater Dei Hospital, Malta

Status: Enrolling

Conditions: Septic Shock; Sepsis

Treatments: Diagnostic Test: Blood transcriptomics and BAL protein profiling

Study type: Observational

Funder types: Other

Identifiers

NCT06287684

SINO-MALTA-2024-40 ESICM-22;

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Consent card signed

Exclusion criteria

• Consent card not signed
• Pregnancy
• Prisoners
• Elective cardiac surgery patients with an uncomplicated stay.

Trial design

460 participants in 3 patient groups

Sepsis (all-cause)

Description:

Suspected infection accompanied by organ dysfunction identified as a total SOFA score ≥ 2 points diagnosed within 24 hours after ITU admission. Definition in line with the Sepsis-3 criteria.

Non-infectious critical illness

Description:

Patients admitted to the ITU with non-infectious etiologies, including trauma.

Control subjects

Description:

Age-, sex-, and comorbidity-matched participants from the community or long term care facility