SepsisSEPSI-spliceNCT07418801
Role of RNA Metabolism Alterations in Persistent Immune Dysfunction After Sepsis
An observational study of Sepsis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
This study includes adult ICU patients with sepsis (according to SEPSIS 3.0) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 290 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2026to 1 Mar 2028
- How long will I take part?
- 48 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patients hospitalized in the ICU at Louis Mourier Hospital with either sepsis according to SEPSIS 3.0 criteria or a severe non-infectious condition. The study also includes a healthy ambulatory control group without infection.
- Septic patients group: Age ≥ 18 years Hospitalized in Intensive Care Medicine Suspected or confirmed infection SOFA score ≥ 2
- Critically ill non-septic patients group: Age ≥ 18 years Hospitalized in Intensive Care Medicine No infection (neither suspected nor confirmed) SOFA score ≥ 2
- Healthy control group Age ≥ 18 years Ambulatory patient (not hospitalized) No infection at the time of consultation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Anesthésie
Colombes
Médecine Intensive Réanimation -Hôpital Louis Mourier
Colombes
About this study
Official title: Rôle Des Altérations Du Métabolisme De L'ARN Dans La Persistance Des Perturbations Immunitaires Au Décours Du Sepsis
This study includes adult ICU patients with sepsis (according to SEPSIS 3.0) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital. It is a prospective multicentre observational study aiming to describe leukocyte transcriptome changes and molecular trajectories (endotypes) during the acute, recovery, and convalescence phases of sepsis. A total of 290 participants will be included: 200 septic patients, 50 critically ill non-septic patients, and 40 control participants.
Read the detailed description
The study will be a prospective, multicentre, observational study including adult ICU patients hospitalized with sepsis (according to SEPSIS 3.0 definitions) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital.
Participants will be assigned to one of three groups:
- Septic patients group: 200 patients with suspected or documented infection and a SOFA score ≥2.
- Critically ill non-septic patients group: 50 patients without infection and a SOFA score ≥2.
- Control group: 40 ambulatory participants without infection, matched for age and sex.
Blood samples for transcriptome and immunomonitoring analyses will be collected at predefined time points during ICU stay and post-ICU follow-up (J1, J3, J7, J14, M3, M6, M12). Routine clinical and laboratory parameters will also be recorded.
The primary objective is to describe longitudinal molecular trajectories (endotypes) of circulating leukocytes over the natural course of sepsis. The primary endpoint is the identification of molecular endotypes from sequential transcriptome analyses.
Secondary analyses will compare molecular profiles between septic and non-septic patients, evaluate the effects of alternative splicing on the cellular proteome, and correlate endotypes with clinical outcomes during ICU stay and up to 12 months post-inclusion. Bioinformatic methods (JLCMM, KmL) and pathway analysis (Ingenuity Pathway Analysis, Qiagen) will be used to identify patient groups with similar molecular profiles over time.
- Conditions
- Sepsis
- Keywords
- Sepsis, Endotypes, Molecular trajectories, Transcriptomics, Leukocytes, Acute phase, Recovery phase, Convalescence
- Medical subject headings
- Sepsis, Convalescence
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 |
|---|---|---|
| Septic Patients | Adult ICU patients hospitalized with sepsis according to SEPSIS 3.0 definitions. Inclusion criteria: age ≥ 18 years, suspected or documented infection, and SOFA score ≥ 2. No specific intervention; observational study collecting clinical and biological data including leukocyte transcriptome analyses. | |
| Critically Ill Non-Septic Patients | Adult ICU patients hospitalized with severe non-infectious conditions, without infection. Inclusion criteria: age ≥ 18 years, SOFA score ≥ 2. No specific intervention; observational study collecting clinical and biological data including leukocyte transcriptome analyses. | |
| Control Patients | Ambulatory adult patients (not hospitalized) without infection at the time of consultation. Inclusion criteria: age ≥ 18 years. No specific intervention; blood samples will be collected for transcriptome and immunomonitoring analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal leukocyte transcriptomic endotype classification
Classification of patients into longitudinal leukocyte transcriptomic endotypes based on sequential circulating leukocyte RNA sequencing. Endotype membership will be determined using transcriptomic profiling and reported as categorical group assignment over time, including comparison with critically ill non-infected control patients.
Measured: From Day 1 to Month 12 after sepsis onset
Secondary outcomes (9)
Alternative splicing events in monocytes
Differential splice variant expression in circulating monocytes, measured by RNA sequencing over time in sepsis and control patients.
Measured: From Day 1 to Month 12 after sepsis onset
ICU length of stay
Length of ICU stay, measured in days from ICU admission to ICU discharge.
Measured: From ICU admission to ICU discharge
ICU mortality
All-cause mortality during ICU stay, reported as % of patients.
Measured: From ICU admission to ICU discharge
Nosocomial infections during ICU stay
Percentage of patients with ≥1 nosocomial infection during ICU stay.
Measured: From ICU admission to ICU discharge
Rehospitalizations within 12 months
Number of rehospitalizations for any cause within 12 months post-ICU discharge.
Measured: From ICU discharge to 12 months after sepsis diagnosis
New infectious episodes within 12 months
Percentage of patients with ≥1 new infectious episode within 12 months post-ICU discharge.
Measured: From ICU discharge to 12 months after sepsis diagnosis
Cardiovascular events within 12 months
Percentage of patients with ≥1 cardiovascular event (MI, stroke, heart failure) within 12 months post-ICU discharge.
Measured: From ICU discharge to 12 months after sepsis diagnosis
Incidence of clinical complications by longitudinal transcriptomic endotype
Percentage of patients experiencing ≥1 predefined clinical complication according to longitudinal transcriptomic endotype membership.
Measured: From Day 1 to Month 12 after sepsis onset
Genetic variants associated with longitudinal transcriptomic endotypes
Frequency of selected genetic polymorphisms associated with longitudinal transcriptomic endotype membership, assessed using genome-wide genotyping arrays.
Measured: From Day 1 to Month 12 after sepsis onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 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 Assistance Publique - Hôpitaux de ParisThe 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
- 290 participants (estimated)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418801
- Sponsor's protocol ID
- APHP251573
- Other IDs
- 2025-A02505-44
- Acronym
- SEPSI-splice
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle Des Altérations Du Métabolisme De L'ARN Dans La Persistance Des Perturbations Immunitaires Au Décours Du Sepsis
- ClinicalTrials.gov ID
- NCT07418801
- Acronym / sponsor ID
- SEPSI-splice / APHP251573
- Conditions
- Sepsis
- Keywords
- Sepsis, Endotypes, Molecular trajectories, Transcriptomics, Leukocytes, Acute phase, Recovery phase, Convalescence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Feb 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 study includes adult ICU patients with sepsis (according to SEPSIS 3.0) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital. It is a prospective multicentre observational study aiming to describe leukocyte transcriptome changes and molecular trajectories (endotypes) during the acute, recovery, and convalescence phases of sepsis. A total of 290 participants will be included: 200 septic patients, 50 critically ill non-septic patients, and 40 control participants.
Detailed description
The study will be a prospective, multicentre, observational study including adult ICU patients hospitalized with sepsis (according to SEPSIS 3.0 definitions) or critically ill non-septic patients with severe non-infectious conditions at Louis Mourier Hospital.
Participants will be assigned to one of three groups:
- Septic patients group: 200 patients with suspected or documented infection and a SOFA score ≥2.
- Critically ill non-septic patients group: 50 patients without infection and a SOFA score ≥2.
- Control group: 40 ambulatory participants without infection, matched for age and sex.
Blood samples for transcriptome and immunomonitoring analyses will be collected at predefined time points during ICU stay and post-ICU follow-up (J1, J3, J7, J14, M3, M6, M12). Routine clinical and laboratory parameters will also be recorded.
The primary objective is to describe longitudinal molecular trajectories (endotypes) of circulating leukocytes over the natural course of sepsis. The primary endpoint is the identification of molecular endotypes from sequential transcriptome analyses.
Secondary analyses will compare molecular profiles between septic and non-septic patients, evaluate the effects of alternative splicing on the cellular proteome, and correlate endotypes with clinical outcomes during ICU stay and up to 12 months post-inclusion. Bioinformatic methods (JLCMM, KmL) and pathway analysis (Ingenuity Pathway Analysis, Qiagen) will be used to identify patient groups with similar molecular profiles over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Septic Patients | – | –Adult ICU patients hospitalized with sepsis according to SEPSIS 3.0 definitions. Inclusion criteria: age ≥ 18 years, suspected or documented infection, and SOFA score ≥ 2. No specific intervention; observational study collecting clinical and biological data including leukocyte transcriptome analyses. |
| Critically Ill Non-Septic Patients | – | –Adult ICU patients hospitalized with severe non-infectious conditions, without infection. Inclusion criteria: age ≥ 18 years, SOFA score ≥ 2. No specific intervention; observational study collecting clinical and biological data including leukocyte transcriptome analyses. |
| Control Patients | – | –Ambulatory adult patients (not hospitalized) without infection at the time of consultation. Inclusion criteria: age ≥ 18 years. No specific intervention; blood samples will be collected for transcriptome and immunomonitoring analyses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients hospitalized in the ICU at Louis Mourier Hospital with either sepsis according to SEPSIS 3.0 criteria or a severe non-infectious condition. The study also includes a healthy ambulatory control group without infection.
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
Longitudinal leukocyte transcriptomic endotype classification
Time frame: From Day 1 to Month 12 after sepsis onset
Classification of patients into longitudinal leukocyte transcriptomic endotypes based on sequential circulating leukocyte RNA sequencing. Endotype membership will be determined using transcriptomic profiling and reported as categorical group assignment over time, including comparison with critically ill non-infected control patients.
9 secondary outcomes
Alternative splicing events in monocytes
Time frame: From Day 1 to Month 12 after sepsis onset
ICU length of stay
Time frame: From ICU admission to ICU discharge
ICU mortality
Time frame: From ICU admission to ICU discharge
Nosocomial infections during ICU stay
Time frame: From ICU admission to ICU discharge
Rehospitalizations within 12 months
Time frame: From ICU discharge to 12 months after sepsis diagnosis
New infectious episodes within 12 months
Time frame: From ICU discharge to 12 months after sepsis diagnosis
Cardiovascular events within 12 months
Time frame: From ICU discharge to 12 months after sepsis diagnosis
Incidence of clinical complications by longitudinal transcriptomic endotype
Time frame: From Day 1 to Month 12 after sepsis onset
Genetic variants associated with longitudinal transcriptomic endotypes
Time frame: From Day 1 to Month 12 after sepsis onset
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Fabrice Uhel (01 47 60 61 93, fabrice.uhel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal leukocyte transcriptomic endotype classification (time frame: From Day 1 to Month 12 after sepsis onset). 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 27 Feb 2026.