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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04439617
Other study ID # QUENOT 2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date March 30, 2020

Study information

Verified date June 2020
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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