COMPACT: COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit

Sponsor

University Hospital, Limoges (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05671159

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patient admitted in intensive care unit (ICU) for acute infection whether it be viral or bacterial had major impairment of the immune response. One hallmark of the immune impairment is presence of immature granulocyte (IG) in blood. Depend of initial trigger (virus or bacteria) concentration, phenotype and function of IG seems to be different. In this prospective trial, immature granulocytes will be analyzed in depth in immunocompetent patients hospitalized in the intensive care unit for an acute viral or bacterial infection.

Condition or Disease	Intervention/Treatment	Phase
Viral Infection Sepsis	Other: Blood sample	N/A

Detailed Description

Granulocytes are a key actor of immune response during acute viral or bacterial infection. During their maturation in bone marrow they went from immature form to mature form. In physiological condition only mature form are present in blood. However, in case of acute viral or bacterial infection, immature granulocytes (CD10low/CD16low) could be released in blood. But concentration, phenotype and function of these IG seems to be different between bacterial and viral infection. Indeed, in bacterial infection, concentration of IG is high (> 20%) and they expressed CD64 and CD123. In case of viral infection, blood concentration of IG is lower and they expressed CD62-L. These phenotype differences are probably associated with functional modification. A more precise characterization of the phenotype and functions of IG according to the stimulus (bacterial or viral) could provide a better understanding of the innate immune response in patients hospitalized in ICU for acute infection. The investigators will analysis by flow cytometry IG subsets (PDL1 CD62L LOX-1 CD45 CD64 CD15 CD123 CD16 CD10 CRTH2) of adult immunocompetent patient hospitalized in ICU for less than 24 hours for acute infection. Transcriptomic and cytokine analysis will be also performed. Infectious status will be validated by a blind adjudication committee which will classify patient in certain bacterial infection, certain viral infection, co-infection and no confirmed infection.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Jan 16, 2024

Anticipated Study Completion Date :

Jan 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bacterial infection	Other: Blood sample A supplementary blood sample will be taken including a 5mL EDTA tube and a paxgene tube
Other: viral infection	Other: Blood sample A supplementary blood sample will be taken including a 5mL EDTA tube and a paxgene tube

Arm

Intervention/Treatment

Experimental: bacterial infection

Other: Blood sample

A supplementary blood sample will be taken including a 5mL EDTA tube and a paxgene tube

Other: viral infection

Other: Blood sample

A supplementary blood sample will be taken including a 5mL EDTA tube and a paxgene tube

Outcome Measures

Primary Outcome Measures

Granules expressing CD123 and CD64 [Day 0]
Measurement by flow cytometry of the percentage of granules expressing CD123 and CD64 depending on the type of infection (viral or bacterial).

Secondary Outcome Measures

granules expressing CD62-L [Day 0]
Measurement by flow cytometry of the percentage of granules expressing CD62-L according to the type of infection (viral or bacterial).
Immune functions genes expression [Day 0]
Evaluate the expression of genes related to immune functions of the different subpopulations of immature granules by measuring the amount of mRNA
blood concentrations of cytokines [Day 0]
Measurement by multiplex Elisa-test of blood cytokine concentrations (IL-8, IL-1, IL-12p70, IL-6, IL-10, IP-10, TNF-a, IFN-g)
blood concentrations of activation markers [Day 0]
Measurement by multiplex Elisa test of blood concentrations of activation markers (RETN, LCN2, HGF; G-CSF)
Sequential Organ Failure Assessment (SOFA) score [Day 0]
Evolution of a modified Sequential (Sepsis-Related) Organ Failure Assessment (SOFA) score (no gradation of the neurologic system) at day 0. Min value =0. Max value =20 . The highest score means the worst situation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Bacterial infection:
Adult patient hospitalized for less than 24 hours in ICU for community documented sepsis
Vasopressor support
SOFA score > 4
Viral infection:
Adult patient hospitalized for less than 24 hours in ICU for confirmed viral acute infection.
High flow oxygen, non-invasive or invasive ventilation since less than 24 hours
Moderate to severe ARDS with PaO2/FiO2 < 200mmHg and a FiO2 ≥ 0.6.