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

Primary Purpose

Viral Infection, Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Viral Infection focused on measuring bacteria, virus, Immune response, acute infection, immature granulocyte

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: Bacterial infection: Antibiotics or hospitalized in ICU in the previous 3 months Immunocompromized patient Ongoing acute or chronic viral infection Viral infection: Antibiotics or hospitalized in ICU in the previous 3 months Immunocompromized patient Current antibiotics Ongoing chronic viral infection.

Sites / Locations

  • Limoges University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

bacterial infection

viral infection

Arm Description

Outcomes

Primary Outcome Measures

Granules expressing CD123 and CD64
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
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
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
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
Measurement by multiplex Elisa test of blood concentrations of activation markers (RETN, LCN2, HGF; G-CSF)
Sequential Organ Failure Assessment (SOFA) score
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

Full Information

First Posted
October 28, 2022
Last Updated
March 15, 2023
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT05671159
Brief Title
COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit
Acronym
COMPACT
Official Title
COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2023 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Infection, Sepsis
Keywords
bacteria, virus, Immune response, acute infection, immature granulocyte

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bacterial infection
Arm Type
Experimental
Arm Title
viral infection
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
A supplementary blood sample will be taken including a 5mL EDTA tube and a paxgene tube
Primary Outcome Measure Information:
Title
Granules expressing CD123 and CD64
Description
Measurement by flow cytometry of the percentage of granules expressing CD123 and CD64 depending on the type of infection (viral or bacterial).
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
granules expressing CD62-L
Description
Measurement by flow cytometry of the percentage of granules expressing CD62-L according to the type of infection (viral or bacterial).
Time Frame
Day 0
Title
Immune functions genes expression
Description
Evaluate the expression of genes related to immune functions of the different subpopulations of immature granules by measuring the amount of mRNA
Time Frame
Day 0
Title
blood concentrations of cytokines
Description
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)
Time Frame
Day 0
Title
blood concentrations of activation markers
Description
Measurement by multiplex Elisa test of blood concentrations of activation markers (RETN, LCN2, HGF; G-CSF)
Time Frame
Day 0
Title
Sequential Organ Failure Assessment (SOFA) score
Description
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
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: Bacterial infection: Antibiotics or hospitalized in ICU in the previous 3 months Immunocompromized patient Ongoing acute or chronic viral infection Viral infection: Antibiotics or hospitalized in ICU in the previous 3 months Immunocompromized patient Current antibiotics Ongoing chronic viral infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas DAIX, MD
Phone
555066983
Ext
+33
Email
thomas.daix@chu-limoges.fr
Facility Information:
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
thomas DAIX, MD
Email
thomas.daix@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Thomas DAIX, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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