SepsisMPR-PPI-SPMsNCT07353970
Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro-Resolving Mediators
An observational study of Sepsis and Severe Infection, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
This is a prospective observational study involving adult patients with severe infection who are admitted to the intensive care unit (ICU). Severe infection and sepsis are major causes of death worldwide. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Severe Infection, Multiple Organ Dysfunction Syndrome
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 16 Jan 2028
- How long will I take part?
- 28 Days
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients with severe infection or sepsis admitted to a tertiary academic medical center. Both male and female patients aged 18 years or older are eligible. All participants receive standard clinical care, and no experimental treatments are provided within this study.
Who may be able to join
- Age ≥ 18 years
- Admission to the intensive care unit (ICU)
- Diagnosis of severe infection or sepsis, as determined by the treating physician according to current clinical criteria
- Ability to obtain blood samples as part of routine clinical care within 24-48 hours after ICU admission
- Informed consent provided by the patient or legally authorized representative (when applicable)
Who cannot join
- Known pregnancy
- Known immunosuppressive disease (e.g., hematologic malignancy, advanced HIV infection)
- Use of long-term immunosuppressive therapy or systemic corticosteroids prior to ICU admission
- Pre-existing end-stage disease with expected survival < 28 days (e.g., end-stage cancer receiving palliative care)
- Enrollment in interventional clinical trials that may influence immune or inflammatory responses
- Refusal of informed consent by the patient or legal representative
- Patients in whom blood sampling or follow-up is not feasible (e.g., expected transfer, withdrawal of life-sustaining treatment within 24 hours)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a prospective observational study involving adult patients with severe infection who are admitted to the intensive care unit (ICU). Severe infection and sepsis are major causes of death worldwide. Many patients experience uncontrolled inflammation or immune suppression, but current tests are limited in identifying which patients are at highest risk.
This study focuses on specialized pro-resolving mediators (SPMs), a group of naturally occurring lipid molecules that help the body turn off inflammation and promote healing. Blood samples that are collected during routine clinical care will be used to measure levels of SPMs. No additional blood draws or experimental treatments will be performed.
Read more
The purpose of this study is to understand how SPM levels change over time in patients with severe infection and how these changes relate to organ function and outcomes such as survival. By combining SPM measurements with routine laboratory results, immune cell counts, and imaging findings, the study aims to identify different clinical phenotypes and to develop tools that may help doctors recognize high-risk patients earlier in the future.
All participants will receive standard medical care determined by their treating physicians. No experimental drugs or interventions are given as part of this study.
Read the detailed description
Severe infection and sepsis remain leading causes of morbidity and mortality worldwide. Although antimicrobial therapy and organ support have improved, many critically ill patients continue to experience poor outcomes. Increasing evidence indicates that failure to appropriately resolve inflammation plays a key role in organ dysfunction and mortality. Specialized pro-resolving mediators (SPMs) are endogenous lipid mediators that actively terminate inflammation, promote clearance of pathogens and apoptotic cells, and support tissue repair. However, their role in human severe infection has not been systematically investigated in prospective clinical cohorts.
This study is a prospective observational cohort study enrolling adult patients with severe infection admitted to the intensive care unit (ICU). Approximately 300 patients are expected to be included. Peripheral blood samples obtained during routine clinical care on days 1, 3, and 7 after ICU admission will be analyzed. Plasma SPMs, including resolvins, protectins, and maresins, will be quantified using liquid chromatography-tandem mass spectrometry. Routine clinical data, including demographic characteristics, laboratory tests, immune cell subsets, coagulation indicators, severity scores (SOFA and APACHE II), organ support therapies, and 28-day outcomes will be recorded.
The study has four major objectives:
to describe the temporal profiles of SPMs in severe infection
to determine associations between SPM levels and adverse outcomes including 28-day mortality and organ failure
to identify biologically and clinically meaningful phenotypes driven by SPM signatures through multivariate clustering and machine-learning approaches
to explore mechanistic pathways linking SPMs with immune responses, coagulation disturbances, organ dysfunction, and clinical prognosis
No experimental medications or interventional procedures are administered as part of this study. All treatments are determined exclusively by the treating physicians according to routine clinical practice. No genetic testing or DNA extraction will be performed from collected samples.
The expected outcome of this study is the development of an SPM-based precision phenotyping framework that may support individualized risk assessment and potential future therapeutic strategies targeting impaired inflammation resolution.
- Keywords
- Specialized pro-resolving mediators, SPM, Resolvin D1, Immune resolution, Inflammation resolution, Critical care
- Medical subject headings
- Sepsis, Infections, Multiple Organ Failure, Critical Illness
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 |
|---|---|---|
| Severe Infection ICU Cohort Adult patients | Adult patients with severe infection admitted to the intensive care unit (ICU). All participants receive standard clinical care as determined by their treating physicians. No experimental interventions are assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
All-cause mortality assessed within 28 days after admission to the intensive care unit.
Measured: From the date of ICU admission until death from any cause, assessed up to 28 days
Secondary outcomes (3)
ICU length of stay
Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
Measured: From ICU admission to ICU discharge, assessed up to 28 days.
Organ dysfunction
Organ dysfunction assessed using routinely collected clinical data during the first 28 days after ICU admission
Measured: Organ dysfunction assessed using routinely collected clinical data from ICU admission through day 28.
Secondary infection during ICU stay
Secondary infection defined as a newly diagnosed infection occurring after ICU admission, confirmed by clinical signs, microbiological evidence, and/or initiation of targeted antimicrobial therapy, based on routinely collected clinical data.
Measured: From the date of ICU admission until the occurrence of a secondary infection or ICU discharge, whichever occurred first, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Jan 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.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353970
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-135
- Acronym
- MPR-PPI-SPMs
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves sensitive clinical information, and data sharing is not covered by the current ethics approval. Data will be used solely for the purposes specified in the approved study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro-Resolving Mediators
- ClinicalTrials.gov ID
- NCT07353970
- Acronym / sponsor ID
- MPR-PPI-SPMs / SAHoWMU-CR2025-03-135
- Keywords
- Specialized pro-resolving mediators, SPM, Resolvin D1, Immune resolution, Inflammation resolution, Critical care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 16 Jan 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
This is a prospective observational study involving adult patients with severe infection who are admitted to the intensive care unit (ICU). Severe infection and sepsis are major causes of death worldwide. Many patients experience uncontrolled inflammation or immune suppression, but current tests are limited in identifying which patients are at highest risk.
This study focuses on specialized pro-resolving mediators (SPMs), a group of naturally occurring lipid molecules that help the body turn off inflammation and promote healing. Blood samples that are collected during routine clinical care will be used to measure levels of SPMs. No additional blood draws or experimental treatments will be performed.
The purpose of this study is to understand how SPM levels change over time in patients with severe infection and how these changes relate to organ function and outcomes such as survival. By combining SPM measurements with routine laboratory results, immune cell counts, and imaging findings, the study aims to identify different clinical phenotypes and to develop tools that may help doctors recognize high-risk patients earlier in the future.
All participants will receive standard medical care determined by their treating physicians. No experimental drugs or interventions are given as part of this study.
Detailed description
Severe infection and sepsis remain leading causes of morbidity and mortality worldwide. Although antimicrobial therapy and organ support have improved, many critically ill patients continue to experience poor outcomes. Increasing evidence indicates that failure to appropriately resolve inflammation plays a key role in organ dysfunction and mortality. Specialized pro-resolving mediators (SPMs) are endogenous lipid mediators that actively terminate inflammation, promote clearance of pathogens and apoptotic cells, and support tissue repair. However, their role in human severe infection has not been systematically investigated in prospective clinical cohorts.
This study is a prospective observational cohort study enrolling adult patients with severe infection admitted to the intensive care unit (ICU). Approximately 300 patients are expected to be included. Peripheral blood samples obtained during routine clinical care on days 1, 3, and 7 after ICU admission will be analyzed. Plasma SPMs, including resolvins, protectins, and maresins, will be quantified using liquid chromatography-tandem mass spectrometry. Routine clinical data, including demographic characteristics, laboratory tests, immune cell subsets, coagulation indicators, severity scores (SOFA and APACHE II), organ support therapies, and 28-day outcomes will be recorded.
The study has four major objectives:
to describe the temporal profiles of SPMs in severe infection
to determine associations between SPM levels and adverse outcomes including 28-day mortality and organ failure
to identify biologically and clinically meaningful phenotypes driven by SPM signatures through multivariate clustering and machine-learning approaches
to explore mechanistic pathways linking SPMs with immune responses, coagulation disturbances, organ dysfunction, and clinical prognosis
No experimental medications or interventional procedures are administered as part of this study. All treatments are determined exclusively by the treating physicians according to routine clinical practice. No genetic testing or DNA extraction will be performed from collected samples.
The expected outcome of this study is the development of an SPM-based precision phenotyping framework that may support individualized risk assessment and potential future therapeutic strategies targeting impaired inflammation resolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Infection ICU Cohort Adult patients | – | –Adult patients with severe infection admitted to the intensive care unit (ICU). All participants receive standard clinical care as determined by their treating physicians. No experimental interventions are assigned. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients with severe infection or sepsis admitted to a tertiary academic medical center. Both male and female patients aged 18 years or older are eligible. All participants receive standard clinical care, and no experimental treatments are provided within this study.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Admission to the intensive care unit (ICU)
- Diagnosis of severe infection or sepsis, as determined by the treating physician according to current clinical criteria
- Ability to obtain blood samples as part of routine clinical care within 24-48 hours after ICU admission
- Informed consent provided by the patient or legally authorized representative (when applicable)
Key exclusion criteria (7 listed)
- Known pregnancy
- Known immunosuppressive disease (e.g., hematologic malignancy, advanced HIV infection)
- Use of long-term immunosuppressive therapy or systemic corticosteroids prior to ICU admission
- Pre-existing end-stage disease with expected survival < 28 days (e.g., end-stage cancer receiving palliative care)
- Enrollment in interventional clinical trials that may influence immune or inflammatory responses
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
28-day all-cause mortality
Time frame: From the date of ICU admission until death from any cause, assessed up to 28 days
All-cause mortality assessed within 28 days after admission to the intensive care unit.
3 secondary outcomes
ICU length of stay
Time frame: From ICU admission to ICU discharge, assessed up to 28 days.
Organ dysfunction
Time frame: Organ dysfunction assessed using routinely collected clinical data from ICU admission through day 28.
Secondary infection during ICU stay
Time frame: From the date of ICU admission until the occurrence of a secondary infection or ICU discharge, whichever occurred first, assessed up to 28 days
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 21 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves sensitive clinical information, and data sharing is not covered by the current ethics approval. Data will be used solely for the purposes specified in the approved study protocol.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Severe Infection, run by Second Affiliated Hospital of Wenzhou Medical University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shengwei Jin, PhD (+86-15068468153, jinshengwei69@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: From the date of ICU admission until death from any cause, assessed up to 28 days). 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 21 Jan 2026.