Septic ShockPhase 3GRIDNCT02361528
GM-CSF to Decrease ICU Acquired Infections
A Phase 3 study testing Sargramostim: Leukine (Genzyme USA) in people with Septic Shock and Severe Sepsis, run by Hospices Civils de Lyon at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Severe Sepsis
- What is being tested?
- Sargramostim: Leukine (Genzyme USA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 18 sitesFrance
- Study dates
- 14 Sep 2015to 1 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- - 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 .
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Amiens Hopital SUD
Amiens, 80054
CHU Estaing 1 place Lucie et Raymond Aubrac
Clermont-Ferrand, 63003
CHU Gabriel MONTPIED
Clermont-Ferrand, 63003
CHU de Grenoble- Hopital Michallon
Grenoble, 38043
CHU de Grenoble-Hopital Michallon
Grenoble, 38043
Hopital Edouard Herriot
Lyon, 69003
Hopital de la Croix Rousse
Lyon, 69317
APHM Hopital de la Timone
Marseille, 13005
CHU la Conception
Marseille, 13005
APHM Hopital Nord
Marseille, 13915
CHU Montpellier
Montpellier, 34295
Hopital Saint Eloi
Montpellier, 34295
CHU de Nantes
Nantes, 44093
PTMC CHU de Nantes
Nantes, 44093
CHU de Nîmes
Nîmes, 30029
Centre hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU de Saint-Etienne
Saint-Etienne, 42055
CHU Hopital Nord
Saint-Etienne, 42055
About this study
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
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.
- Conditions
- Septic Shock, Severe Sepsis
- Being tested
- Sargramostim: Leukine (Genzyme USA), Placebo
- Keywords
- Septic shock, Severe sepsis, GM-CSF, Immunosuppression, Hospital-acquired infections, ICU-acquired infections, HLA-DR, Monocytes
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sargramostim: Leukine (Genzyme USA)Drug
Leukine: 125 µg/m² daily, subcutaneously, for 5 days.
PlaceboDrug
placebo subcutaneously, for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Leukine | Experimental | Sargramostim: Leukine (Genzyme USA), 125µg/m2 , once per day during 5 days, by subcutaneous route Receives: Drug: Sargramostim: Leukine (Genzyme USA) |
| placebo | Placebo comparator | placebo, once per day during 5 days by subcutaneous route Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients presenting at least one ICU-acquired infection at D28 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.
Measured: At Day 28 or ICU discharge.
Secondary outcomes (4)
Incidence and incidence density of pneumonia, catheter related infections, and urinary tract infections
Measured: At Day 28 or ICU discharge.
Survival at D28, end of ICU and hospital stay, and at 1 year
Measured: At Day 28 or ICU discharge.
Organ failure free days
Measured: At Day 28 or ICU discharge.
Number of serious adverse events and number of patients having presented at least one serious adverse event.
Measured: At Day 28 or ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start14 Sep 2015
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361528
- Sponsor's protocol ID
- 2014.856
- Other IDs
- 2014-001894-15, 2014
- Acronym
- GRID
- Status last verified
- May 2026
- First submitted
- 6 Feb 2015
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vacheron CH, Lepape A, Venet F, Monneret G, Gueyffier F, Boutitie F, Vallin H, Schwebel C, Maucort-Boulch D, Friggeri A; GRID Study Group. Granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients presenting sepsis-induced immunosuppression: The GRID randomized controlled trial. J Crit Care. 2023 Dec;78:154330. doi: 10.1016/j.jcrc.2023.154330. Epub 2023 May 31.
PubMed 37267804
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02361528
- Acronym / sponsor ID
- GRID / 2014.856
- Conditions
- Septic Shock, Severe Sepsis
- Keywords
- Septic shock, Severe sepsis, GM-CSF, Immunosuppression, Hospital-acquired infections, ICU-acquired infections, HLA-DR, Monocytes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leukine | Experimental | Drug: Sargramostim: Leukine (Genzyme USA)Sargramostim: Leukine (Genzyme USA), 125µg/m2 , once per day during 5 days, by subcutaneous route |
| placebo | Placebo comparator | Drug: Placeboplacebo, once per day during 5 days by subcutaneous route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sargramostim: Leukine (Genzyme USA)Leukine: 125 µg/m² daily, subcutaneously, for 5 days. | Drug | Leukine |
| Placeboplacebo subcutaneously, for 5 days | Drug | placebo |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 37267804Vacheron CH, Lepape A, Venet F, Monneret G, Gueyffier F, Boutitie F, Vallin H, Schwebel C, Maucort-Boulch D, Friggeri A; GRID Study Group. Granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients presenting sepsis-induced immunosuppression: The GRID randomized controlled trial. J Crit Care. 2023 Dec;78:154330. doi: 10.1016/j.jcrc.2023.154330. Epub 2023 May 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sargramostim: Leukine (Genzyme USA) in people with Septic Shock and Severe Sepsis, run by Hospices Civils de Lyon at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients presenting at least one ICU-acquired infection at D28 or ICU discharge. (time frame: At Day 28 or ICU discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.