Skip to main content
OpenTrials
Completed

NCT Number: NCT02361528

GM-CSF to Decrease ICU Acquired Infections

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Severe Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens Hopital SUD, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

ICU patients presenting a severe sepsis or a septic shock associated with a sepsis-induced immunosuppression.

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

Exclusion criteria

  • - Therapeutic limitation
  • Evolutive hemopathy, neutropenia < 500/mm3, stemcell transplant
  • Solid tumor with on-going chemotherapy or radiotherapy
  • Human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3
  • Immunosuppressive treatment (including corticosteroid at immunosuppressive dose : > 10 mg equivalent prednisolone and cumulative dose > 700 mg)
  • Primary immunodeficiency .
  • Extra corporeal circulation within one month
  • Recent cardio-pulmonary resuscitation (within the current clinical episode)
  • Patients admitted in ICU for extensive burns
  • Contraindications to sargramostim
  • Pregnant or lactating women
  • Participation to another interventional study.

Treatment and study plan

Sargramostim: Leukine (Genzyme USA)

Drug

Leukine: 125 µg/m² daily, subcutaneously, for 5 days.

Placebo

Drug

placebo subcutaneously, for 5 days

Primary outcomes

  1. Number of patients presenting at least one ICU-acquired infection at D28 or ICU discharge.

    Time frame: At Day 28 or ICU discharge.

    ICU-acquired infections will be recorded in accordance with the definitions of the European CDC used in the French network of IAI surveillance Rea Raisin. An independent committee blinded to treatment group will ensure the classification of hospital-acquired infections.

Secondary outcomes

  1. Incidence and incidence density of pneumonia, catheter related infections, and urinary tract infections

    Time frame: At Day 28 or ICU discharge.

  2. Survival at D28, end of ICU and hospital stay, and at 1 year

    Time frame: At Day 28 or ICU discharge.

  3. Organ failure free days

    Time frame: At Day 28 or ICU discharge.

  4. Number of serious adverse events and number of patients having presented at least one serious adverse event.

    Time frame: At Day 28 or ICU discharge.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

A Double-Blind, Randomized, Placebo-controlled Multicenter Trial of GRanulocyte-Macrophage Colony-stimulating Factor Administration to Decrease ICU Acquired Infections in Sepsis-induced ImmunoDepression

Acronym: GRID

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2015
Registry last updated
May 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.