Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMater Dei Hospital, Malta

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years

Consent card signed

Disqualifiers

Consent card not signed

Pregnancy

Prisoners

Elective cardiac surgery patients with an uncomplicated stay.

Trial population

All-cause sepsis, non-infectious critical illness, and control participants

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

460 Participants
are grouped into 3 trial groups
Group A: Sepsis (all-cause)
Group B: Non-infectious critical illness
Group C: Control subjects

Trial outcomes

Primary outcomes

1

Molecular subtype assignments

Molecular subtype classification of sepsis patients using a consensus transcriptomic subtype model

Time frame
Through study completion, an average of 2 year
2

Molecular information about the host response in patients with sepsis

Measurement of soluble mediators of host immune responses, including inflammation, coagulation, endothelial function

Time frame
Through study completion, an average of 2 year

Secondary outcomes

1

Survival

Assessment of survival

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mater Dei Hospital, Malta

Lead sponsor

University of Malta

Collaborator