SepticaemiaMyelochondriaNCT04439617
Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital
An observational study of Septicaemia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Severe infections (sepsis) are a common cause of admission to the intensive care unit. They represent a significant health risk for patients in the short and medium term. They are particularly linked to a change in the function of immune cells. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septicaemia
- What is being tested?
- blood examination
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 30 Mar 2020
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in the ICU with or without sepsis.
Who may be able to join
- Adult person who has given written consent (or consent obtained from a heath care proxy) hospitalized in an ICU with or without sepsis (with or without infection)
Who cannot join
- Person not affiliated or not benefiting from national health insurance
- Person under legal protection (curatorship, guardianship, safeguard of justice)
- Pregnant, parturient or breastfeeding woman
- Patient who was hospitalized within 3 months prior to inclusion for sepsis.
- Patients receiving known treatment for mitochondrial function modulation, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil).
Trial locations and contacts
1 site in 1 country.
About this study
Severe infections (sepsis) are a common cause of admission to the intensive care unit. They represent a significant health risk for patients in the short and medium term. They are particularly linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of myeloid cells, is observed. This situation leads to a worsening of the infection, so it should be avoided because it represents a danger for the patient even when they ar receiving antibiotics. At present, these events are still very poorly understood. Research is essential to understand how this state of immunosuppression of myeloid cells is established in order to adapt existing treatments or find new ones.
Laboratory studies on animal models of septicaemia have shown that this state of immunosuppression of myeloid cells is closely linked to a change in the production of energy by myeloid cells (monocytes and macrophages). The functioning 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 septicaemia.
The objective of this study is to verify whether alterations in mitochondrial function in myeloid cells also occur in patients with bacterial infection compared to patients without bacterial infection.
- Conditions
- Septicaemia
- Being tested
- blood examination
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood examinationBiological
use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function
| Study group | Role | What they receive |
|---|---|---|
| sepsis patient | Not described Receives: Biological: blood examination | |
| Sepsis-free patient | Not described Receives: Biological: blood examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of mitophagy in circulating monocytes
Measurement of mitochondrial density and PINK1 protein expression by flow cytometry in circulating monocytes (total population and subpopulation of conventional, intermediate and non-conventional monocytes (CD33, CD16 and CD14 monocyte markers)
Measured: <24 hours after hospitalization in intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Nov 2019
- Primary completion30 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepticaemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 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
- NCT04439617
- Sponsor's protocol ID
- QUENOT 2019
- Acronym
- Myelochondria
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patoli D, Mignotte F, Deckert V, Dusuel A, Dumont A, Rieu A, Jalil A, Van Dongen K, Bourgeois T, Gautier T, Magnani C, Le Guern N, Mandard S, Bastin J, Djouadi F, Schaeffer C, Guillaumot N, Narce M, Nguyen M, Guy J, Dargent A, Quenot JP, Rialland M, Masson D, Auwerx J, Lagrost L, Thomas C. Inhibition of mitophagy drives macrophage activation and antibacterial defense during sepsis. J Clin Invest. 2020 Nov 2;130(11):5858-5874. doi: 10.1172/JCI130996.
PubMed 32759503
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital
- ClinicalTrials.gov ID
- NCT04439617
- Acronym / sponsor ID
- Myelochondria / QUENOT 2019
- Conditions
- Septicaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 19 Jun 2020 (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 common cause of admission to the intensive care unit. They represent a significant health risk for patients in the short and medium term. They are particularly linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of myeloid cells, is observed. This situation leads to a worsening of the infection, so it should be avoided because it represents a danger for the patient even when they ar receiving antibiotics. At present, these events are still very poorly understood. Research is essential to understand how this state of immunosuppression of myeloid cells is established in order to adapt existing treatments or find new ones.
Laboratory studies on animal models of septicaemia have shown that this state of immunosuppression of myeloid cells is closely linked to a change in the production of energy by myeloid cells (monocytes and macrophages). The functioning 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 septicaemia.
The objective of this study is to verify whether alterations in mitochondrial function in myeloid cells also occur in patients with bacterial infection compared to patients without bacterial infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis patient | – | Biological: blood examination |
| Sepsis-free patient | – | Biological: blood examination |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in the ICU with or without sepsis.
Key inclusion criteria (1 listed)
- Adult person who has given written consent (or consent obtained from a heath care proxy) hospitalized in an ICU with or without sepsis (with or without infection)
Key exclusion criteria (5 listed)
- Person not affiliated or not benefiting from national health insurance
- Person under legal protection (curatorship, guardianship, safeguard of justice)
- Pregnant, parturient or breastfeeding woman
- Patient who was hospitalized within 3 months prior to inclusion for sepsis.
- Patients receiving known treatment for mitochondrial function modulation, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil).
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 examinationuse of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function | Biological | Sepsis-free patient, sepsis patient |
Primary outcome
Level of mitophagy in circulating monocytes
Time frame: <24 hours after hospitalization in intensive care
Measurement of mitochondrial density and PINK1 protein expression by flow cytometry in circulating monocytes (total population and subpopulation of conventional, intermediate and non-conventional monocytes (CD33, CD16 and CD14 monocyte markers)
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 2 Feb 2026.
- Results publication: PubMed 32759503Patoli D, Mignotte F, Deckert V, Dusuel A, Dumont A, Rieu A, Jalil A, Van Dongen K, Bourgeois T, Gautier T, Magnani C, Le Guern N, Mandard S, Bastin J, Djouadi F, Schaeffer C, Guillaumot N, Narce M, Nguyen M, Guy J, Dargent A, Quenot JP, Rialland M, Masson D, Auwerx J, Lagrost L, Thomas C. Inhibition of mitophagy drives macrophage activation and antibacterial defense during sepsis. J Clin Invest. 2020 Nov 2;130(11):5858-5874. doi: 10.1172/JCI130996.
Related trials for Septicaemia
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
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
Infection, Sepsis
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. 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?
An observational study of Septicaemia, 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 1 inclusion and 5 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 2 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 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 in circulating monocytes (time frame: <24 hours after hospitalization in intensive care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439617, which also lists 1 linked publication.
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 2 Feb 2026.