SepticemiaMIMICNCT05040503
Monitoring Mitophagy In Myeloid Cells Upon Intensive Care
A study testing Blood sampling at inclusion, Blood sampling at 24 hours and Data collection in people with Septicemia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septicemia
- What is being tested?
- Blood sampling at inclusion, Blood sampling at 24 hours and Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2021to 13 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Criteria common to all 4 groups:
- Patient (and/or trusted person/health care proxy or relative) or volunteer who provided oral consent after receiving information about the study, or patient included in emergency situation
- Age ≥ 18 years
- Common criteria for patients
- Admission to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Who cannot join
- Person not affiliated to national health insurance
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnancy or breastfeeding
- Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive treatment or systemic corticosteroid therapy in the 3 months preceding inclusion (> 0.15 mg/kg/d of prednisone equivalent for more than 2 weeks or "bolus" greater than 2mg/kg/d of prednisone equivalent), HIV infection, primary cellular immune deficiency)
- Patients hospitalized within 3 months prior to inclusion for sepsis.
- Patients receiving therapy known to modulate mitochondrial function, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
- Patients with COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.
Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.
The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.
- Conditions
- Septicemia
- Being tested
- Blood sampling at inclusion, Blood sampling at 24 hours, Data collection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling at inclusionBiological
Sampling of 2 tubes of 3 ml:
- patient: H0: 0-6h post-admission
- healthy volunteer: at inclusion
Blood sampling at 24 hoursBiological
Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)
Data collectionOther
clinical and biological medical data for patients and general health data for healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Patients without sepsis | Active comparator | patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital Receives: Biological: Blood sampling at inclusion; Biological: Blood sampling at 24 hours; Other: Data collection |
| Patients with sepsis | Experimental | Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital Receives: Biological: Blood sampling at inclusion; Biological: Blood sampling at 24 hours; Other: Data collection |
| Patients with septic shock | Experimental | Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital Receives: Biological: Blood sampling at inclusion; Biological: Blood sampling at 24 hours; Other: Data collection |
| Healthy volunteers | Active comparator | Not described Receives: Biological: Blood sampling at inclusion; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of mitophagy
Measured: at admission and at 24 hours post-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start25 Aug 2021
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepticemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040503
- Sponsor's protocol ID
- QUENOT 2020-2
- Acronym
- MIMIC
- Status last verified
- Jun 2025
- First submitted
- 30 Aug 2021
- Last updated
- 24 Jun 2025
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Mitophagy In Myeloid Cells Upon Intensive Care
- ClinicalTrials.gov ID
- NCT05040503
- Acronym / sponsor ID
- MIMIC / QUENOT 2020-2
- Conditions
- Septicemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 10 Sep 2021 (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.
Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.
Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.
The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients without sepsis | Active comparator | Biological: Blood sampling at inclusion, Biological: Blood sampling at 24 hours, Other: Data collectionpatient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital |
| Patients with sepsis | Experimental | Biological: Blood sampling at inclusion, Biological: Blood sampling at 24 hours, Other: Data collectionPatients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital |
| Patients with septic shock | Experimental | Biological: Blood sampling at inclusion, Biological: Blood sampling at 24 hours, Other: Data collectionPatients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital |
| Healthy volunteers | Active comparator | Biological: Blood sampling at inclusion, Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient (and/or trusted person/health care proxy or relative) or volunteer who provided oral consent after receiving information about the study, or patient included in emergency situation
- Age ≥ 18 years
- Common criteria for patients
- Admission to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Key exclusion criteria (8 listed)
- Person not affiliated to national health insurance
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person subject to limited judicial protection
- Pregnancy or breastfeeding
- Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive treatment or systemic corticosteroid therapy in the 3 months preceding inclusion (> 0.15 mg/kg/d of prednisone equivalent for more than 2 weeks or "bolus" greater than 2mg/kg/d of prednisone equivalent), HIV infection, primary cellular immune deficiency)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling at inclusionSampling of 2 tubes of 3 ml: * patient: H0: 0-6h post-admission * healthy volunteer: at inclusion | Biological | Healthy volunteers, Patients with sepsis, Patients with septic shock, Patients without sepsis |
| Blood sampling at 24 hoursCollection of 2 tubes of 3 ml (H24: 24-30h post-admission) | Biological | Patients with sepsis, Patients with septic shock, Patients without sepsis |
| Data collectionclinical and biological medical data for patients and general health data for healthy volunteers | Other | Healthy volunteers, Patients with sepsis, Patients with septic shock, Patients without sepsis |
Primary outcome
Level of mitophagy
Time frame: at admission and at 24 hours post-admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling at inclusion, Blood sampling at 24 hours and Data collection in people with Septicemia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 8 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: finished, as of the sponsor's last update on 24 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of mitophagy (time frame: at admission and at 24 hours post-admission). 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 24 Jun 2025.