Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis

Sepsis Clinical Trial

— MENDSEP  

Official title:

Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287684
• Other study ID #: ESICM-22
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Mater Dei Hospital, Malta
• Contact: Brendon Scicluna, Ph.D.
• Phone: +35623401882
• Email: brendon.scicluna[@]um.edu.mt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Acute respiratory tract infection due to community- or hospital-acquired pneumonia

Exclusion Criteria:

• Consent card not signed
• Pregnancy
• Prisoners
• Aspiration pneumonitis
• Patients with ventilator-associated pneumonia

Related Conditions & MeSH terms

• Pneumonia
• Sepsis
• Septic Shock
• Toxemia

Intervention

Diagnostic Test:
• Blood transcriptomics and BAL protein profiling
Paxgene blood tubes will be used for RNA transcriptomics to classify patients as endotypes. BAL fluid will be used to measure protein levels by ELISA.

Locations

Country	Name	City	State
Malta	Mater Dei hospital, Intensive Care Unit	Imsida

Sponsors (3)

Lead Sponsor	Collaborator
Mater Dei Hospital, Malta	European Society of Intensive Care Medicine, University of Malta

Country where clinical trial is conducted

Malta, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient stratification as transcriptomic endotypes	Molecular endotype classification of sepsis patients secondary to pneumonia	Through study completion, an average of 1 year
Primary	Lung endothelial barrier integrity	Measurement of soluble mediators of endothelial function in bronchoalveolar lavage	Through study completion, an average of 1 year
Secondary	Survival	Assessment of survival	2 years