GM-CSF to Decrease ICU Acquired Infections (GRID)
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|ClinicalTrials.gov Identifier: NCT02361528|
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : November 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock Severe Sepsis||Drug: Sargramostim: Leukine (Genzyme USA) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||September 14, 2015|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
Sargramostim: Leukine (Genzyme USA), 125µg/m2 , once per day during 5 days, by subcutaneous route
Drug: Sargramostim: Leukine (Genzyme USA)
Leukine: 125 µg/m² daily, subcutaneously, for 5 days.
Placebo Comparator: placebo
placebo, once per day during 5 days by subcutaneous route
placebo subcutaneously, for 5 days
- 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.
- Incidence and incidence density of pneumonia, catheter related infections, and urinary tract infections [ Time Frame: At Day 28 or ICU discharge. ]
- Survival at D28, end of ICU and hospital stay, and at 1 year [ Time Frame: At Day 28 or ICU discharge. ]
- Organ failure free days [ Time Frame: At Day 28 or ICU discharge. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361528