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NCT Number: NCT06287684

Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Consent card signed

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Molecular subtype assignments

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

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

  2. Molecular information about the host response in patients with sepsis

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

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

Secondary outcomes

  1. Survival

    Time frame: 3 years

    Assessment of survival

Study contacts

Contact information is provided by the study sponsor or research team.

Brendon P. Scicluna, Ph.D.

CONTACT

[email protected]

+35623403869

Stephen C. Sciberras, M.D.

CONTACT

[email protected]

+35625450000

Sponsors and collaborators

Lead sponsor

Mater Dei Hospital, Malta

Other

Collaborators

  • University of Malta

Registry information

Acronym: MENDSEP

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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