GM-CSF to Decrease ICU Acquired Infections

Last updated: October 31, 2019
Sponsor: Hospices Civils de Lyon
Overall Status: Completed

Phase

3

Condition

Soft Tissue Infections

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT02361528
2014.856
  • Ages > 18
  • All Genders

Study Summary

The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009.

The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites.

Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.

Eligibility Criteria

Inclusion

Inclusion Criteria: ICU patients presenting a severe sepsis or a septic shock associated with a sepsis-inducedimmunosuppression.

    • Severe sepsis OR septic shock defined by the association of: at least 2 criteria ofSystemic Inflammation Response Syndrome (SIRS) a clinically or microbiologicallydefined infection and respectively at least one organ failure (level ≥ 2 in one organfailure of the SOFA score) OR the need of a vasopressor treatment (epinephrine ornorepinephrine ≥ 0,25mg/kg/min for at least 6 hrs to maintain a systolic pressure ≥ 90mmHg or a mean arterial pressure ≥ 65 mmHg).
    • AND Sepsis-induced immunosuppression: reduced mHLA-DR levels (< 8,000 monoclonalantibodies (mAb) per cell at D3).

Exclusion

Exclusion Criteria:

    • Therapeutic limitation
  1. Evolutive hemopathy, neutropenia < 500/mm3, stemcell transplant

  2. Solid tumor with on-going chemotherapy or radiotherapy

  3. Human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3

  4. Immunosuppressive treatment (including corticosteroid at immunosuppressive dose : > 10mg equivalent prednisolone and cumulative dose > 700 mg)

  5. Primary immunodeficiency .

  6. Extra corporeal circulation within one month

  7. Recent cardio-pulmonary resuscitation (within the current clinical episode)

  8. Patients admitted in ICU for extensive burns

  9. Contraindications to sargramostim

  10. Pregnant or lactating women

  11. Participation to another interventional study.

Study Design

Total Participants: 166
Study Start date:
September 14, 2015
Estimated Completion Date:
June 01, 2018

Connect with a study center

  • CHU Amiens Hopital SUD

    Amiens, 80054
    France

    Site Not Available

  • CHU Gabriel MONTPIED

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • CHU Estaing 1 place Lucie et Raymond Aubrac

    Clermont-ferrand, 63003
    France

    Site Not Available

  • CHU Gabriel MONTPIED

    Clermont-ferrond, 63003
    France

    Site Not Available

  • CHU de Grenoble- Hopital Michallon

    Grenoble, 38043
    France

    Site Not Available

  • CHU de Grenoble-Hopital Michallon

    Grenoble, 38043
    France

    Site Not Available

  • Hopital Edouard Herriot

    Lyon, 69003
    France

    Site Not Available

  • Hopital de la Croix Rousse

    Lyon, 69317
    France

    Site Not Available

  • APHM Hopital Nord

    Marseille, 13915
    France

    Site Not Available

  • APHM Hopital de la Timone

    Marseille, 13005
    France

    Site Not Available

  • CHU la Conception

    Marseille, 13005
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Saint Eloi

    Montpellier, 34295
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • PTMC CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nîmes

    Nîmes, 30029
    France

    Site Not Available

  • Centre hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • CHU Hopital Nord

    Saint-Etienne, 42055
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Etienne, 42055
    France

    Site Not Available

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