Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

NCT06287684 | Recruiting DMC

• 1 other identifier: SINO-MALTA-2024-40; ESICM-22
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (2)

• Molecular subtype assignments

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

  Through study completion, an average of 2 year

• Molecular information about the host response in patients with sepsis

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

  Through study completion, an average of 2 year

Secondary Outcomes (1)

• Survival

  3 years

Study Arms (3)

Sepsis (all-cause)

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

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

Control subjects

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 18 years
• Consent card signed

You may not qualify if:

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

Sponsors & Collaborators

• Mater Dei Hospital, Malta: lead
• University of Malta: collaborator

Study Sites (1)

Mater Dei hospital, Intensive Therapy Unit

Msida, MSD2080, Malta

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchoalveolar lavage fluid (BAL), whole blood, Paxgene blood, plasma, and serum

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Brendon P. Scicluna, Ph.D.

CONTACT

+35623403869; brendon.scicluna@um.edu.mt

Stephen C. Sciberras, M.D.

CONTACT

+35625450000; stephen.sciberras@gov.mt

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 1, 2024
• Study Start: September 13, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)