Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06287684

Acronym

MENDSEP

Enrollment

460

Registered

2024-03-01

Start date

2023-09-13

Completion date

2028-12-30

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age ≥ 18 years * Consent card signed

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Survival	3 years	Assessment of survival

Countries

Malta

Contacts

Primary ContactBrendon P. Scicluna, Ph.D.

brendon.scicluna@um.edu.mt+35623403869

Backup ContactStephen C. Sciberras, M.D.

stephen.sciberras@gov.mt+35625450000

Outcome results