SepsisMENDSEPNCT06287684
Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis
An observational study of Sepsis and Septic Shock, run by Mater Dei Hospital, Malta at 1 site in Malta.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 460 participants
- Where
- 1 siteMalta
- Study dates
- 13 Sep 2023to 30 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All-cause sepsis, non-infectious critical illness, and control participants
Who may be able to join
- Age ≥ 18 years
- Consent card signed
Who cannot join
- Consent card not signed
- Pregnancy
- Prisoners
- Elective cardiac surgery patients with an uncomplicated stay.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malta1 site, 1 recruiting
- Recruiting
Mater Dei hospital, Intensive Therapy Unit
Msida, MSD2080
Stephen Sciberras, MD, +35625450000, stephen.sciberras@gov.mt
Godfrey Azzopardi, MD, +35625450000, godfrey.a.azzopardi@gov.mt
About this study
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
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular subtype assignments
Molecular subtype classification of sepsis patients using a consensus transcriptomic subtype model
Measured: 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
Measured: Through study completion, an average of 2 year
Secondary outcomes (1)
Survival
Assessment of survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start13 Sep 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Mater Dei Hospital, Malta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malta
- Responsible party
- Principal investigator, Brendon Scicluna, PhD, Mater Dei Hospital, Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287684
- Sponsor's protocol ID
- SINO-MALTA-2024-40; ESICM-22
- Acronym
- MENDSEP
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis
- ClinicalTrials.gov ID
- NCT06287684
- Acronym / sponsor ID
- MENDSEP / SINO-MALTA-2024-40; ESICM-22
- Conditions
- Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Mater Dei Hospital, MaltaUniversity, hospital or other
- Collaborators
- University of Malta
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All-cause sepsis, non-infectious critical illness, and control participants
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Consent card signed
Key exclusion criteria (4 listed)
- Consent card not signed
- Pregnancy
- Prisoners
- Elective cardiac surgery patients with an uncomplicated stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Mater Dei Hospital, Malta at 1 site in Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brendon P. Scicluna, Ph.D. (+35623403869, brendon.scicluna@um.edu.mt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular subtype assignments (time frame: Through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.