GM-CSF to Decrease ICU Acquired Infections (GRID)
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| ClinicalTrials.gov Identifier: NCT02361528 |
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Recruitment Status :
Completed
First Posted : February 11, 2015
Last Update Posted : November 1, 2019
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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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Leukine
Sargramostim: Leukine (Genzyme USA), 125µg/m2 , once per day during 5 days, by subcutaneous route
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Drug: Sargramostim: Leukine (Genzyme USA)
Leukine: 125 µg/m² daily, subcutaneously, for 5 days. |
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Placebo Comparator: placebo
placebo, once per day during 5 days by subcutaneous route
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Drug: Placebo
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. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT02361528 |
| Other Study ID Numbers: |
2014.856 |
| First Posted: | February 11, 2015 Key Record Dates |
| Last Update Posted: | November 1, 2019 |
| Last Verified: | September 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Septic shock Severe sepsis GM-CSF Immunosuppression |
Hospital-acquired infections ICU-acquired infections HLA-DR Monocytes |
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Infections Sepsis Shock, Septic Pathologic Processes Systemic Inflammatory Response Syndrome |
Inflammation Shock Sargramostim Immunologic Factors Physiological Effects of Drugs |