Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥ 18 years

• Consent card signed

Locations
Other Locations
Malta
Mater Dei hospital, Intensive Therapy Unit
RECRUITING
Msida
Contact Information
Primary
Brendon P. Scicluna, Ph.D.
brendon.scicluna@um.edu.mt
+35623403869
Backup
Stephen C. Sciberras, M.D.
stephen.sciberras@gov.mt
+35625450000
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 460
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Mater Dei Hospital, Malta
Collaborators: University of Malta

This content was sourced from clinicaltrials.gov