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

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671159
• Other study ID #: 87RI22_0031(COMPACT)
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2023
• Est. completion date: February 20, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Limoges
• Contact: Thomas DAIX, MD
• Phone: 555066983
• Email: thomas.daix[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: February 20, 2026
• Est. primary completion date: February 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Sepsis
• Viral Infection
• Virus Diseases

Intervention

Other:
• Blood sample
A supplementary blood sample will be taken including a 5mL EDTA tube and a paxgene tube

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Day 0
Secondary	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	Day 0
Secondary	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)	Day 0
Secondary	blood concentrations of activation markers	Measurement by multiplex Elisa test of blood concentrations of activation markers (RETN, LCN2, HGF; G-CSF)	Day 0
Secondary	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	Day 0