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

NCT ID: NCT05671159

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-19
• Study Completion Date: 2026-02-20

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.

Conditions

Viral Infection; Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

bacterial infection

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: OTHER

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

viral infection

Group Type: OTHER

Blood sample

Intervention Type: OTHER

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

Interventions

Blood sample

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Limoges University Hospital

Limoges, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas DAIX, MD

Role: CONTACT

thomas.daix@chu-limoges.fr

555066983 ext. +33

Facility Contacts

thomas DAIX, MD

Role: primary

thomas.daix@chu-limoges.fr

Other Identifiers

87RI22_0031(COMPACT)

Identifier Type: -

Identifier Source: org_study_id