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

NCT05671159 | Recruiting

• 1 other identifier: 87RI22_0031(COMPACT)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Infection; Sepsis

Keywords

bacteria; virus; Immune response; acute infection; immature granulocyte

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0

Secondary Outcomes (5)

• granules expressing CD62-L

  Day 0

• Immune functions genes expression

  Day 0

• blood concentrations of cytokines

  Day 0

• blood concentrations of activation markers

  Day 0

• Sequential Organ Failure Assessment (SOFA) score

  Day 0

Study Arms (2)

bacterial infection

EXPERIMENTAL

Other: Blood sample

viral infection

OTHER

Other: Blood sample

Interventions

Blood sample OTHER

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

bacterial infection; viral infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Virus Diseases; Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Thomas DAIX, MD

CONTACT

555066983; thomas.daix@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: January 4, 2023
• Study Start: February 19, 2023
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)