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NCT Number: NCT05671159

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges University Hospital

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. Granules expressing CD123 and CD64

    Time frame: 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 outcomes

  1. granules expressing CD62-L

    Time frame: Day 0

    Measurement by flow cytometry of the percentage of granules expressing CD62-L according to the type of infection (viral or bacterial).

  2. Immune functions genes expression

    Time frame: Day 0

    Evaluate the expression of genes related to immune functions of the different subpopulations of immature granules by measuring the amount of mRNA

  3. blood concentrations of cytokines

    Time frame: 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)

  4. blood concentrations of activation markers

    Time frame: Day 0

    Measurement by multiplex Elisa test of blood concentrations of activation markers (RETN, LCN2, HGF; G-CSF)

  5. Sequential Organ Failure Assessment (SOFA) score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: COMPACT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 4, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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