Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

NCT ID: NCT06287684

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2028-12-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Non-infectious critical illness

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

No interventions assigned to this group

Control subjects

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Consent card signed

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malta

OTHER

Sponsor Role: collaborator

Mater Dei Hospital, Malta

OTHER

Sponsor Role: lead

Responsible Party

Brendon Scicluna, PhD

Assistant Professor and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mater Dei hospital, Intensive Therapy Unit

Msida, , Malta

Site Status: RECRUITING

Countries

Malta

Central Contacts

Brendon P. Scicluna, Ph.D.

Role: CONTACT

brendon.scicluna@um.edu.mt

+35623403869

Stephen C. Sciberras, M.D.

Role: CONTACT

stephen.sciberras@gov.mt

+35625450000

Facility Contacts

Stephen Sciberras, MD

Role: primary

stephen.sciberras@gov.mt

+35625450000

Godfrey Azzopardi, MD

Role: backup

godfrey.a.azzopardi@gov.mt

+35625450000

Other Identifiers

SINO-MALTA-2024-40; ESICM-22

Identifier Type: -

Identifier Source: org_study_id