NCT04439617

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

June 17, 2020

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    <24 hours after hospitalization in intensive care

Study Arms (2)

sepsis patient

Biological: blood examination

Sepsis-free patient

Biological: blood examination

Interventions

use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function

Sepsis-free patientsepsis patient

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients hospitalized in the ICU with or without sepsis.

You may qualify if:

  • 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)

You may not qualify if:

  • Person not affiliated or not benefiting from national health insurance
  • Person under legal protection (curatorship, guardianship, safeguard of justice)
  • Pregnant, parturient or breastfeeding woman
  • Patients receiving known treatment for mitochondrial function modulation, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

November 1, 2019

Primary Completion

January 30, 2020

Study Completion

March 30, 2020

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations