NCT02361528: GRID

GM-CSF to Decrease ICU Acquired Infections

Completed Phase 3 Last updated 3 September 2025

What this trial tests

Phase 3 trial testing Sargramostim: Leukine (Genzyme USA) in Septic Shock in 166 participants. Completed in 1 June 2018.

Timeline

14 September 2015

Primary endpoint
1 June 2018

1 June 2018

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	166
Start date	14 September 2015
Primary completion	1 June 2018
Estimated completion	1 June 2018
Sites	18 locations across France

Drugs / interventions tested

• Sargramostim: Leukine (Genzyme USA) — full drug profile →
• Placebo

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Severe Sepsis — all drugs for Severe Sepsis →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Septic Shock or Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Precision Immunotherapy for Sepsis.
   Peters van Ton AM, Kox M, Abdo WF, Pickkers P. · · 2018 · cited 113× · PMID 30233566 · DOI 10.3389/fimmu.2018.01926
2. Evidence for Persistent Immune Suppression in Patients Who Develop Chronic Critical Illness After Sepsis.
   Stortz JA, Murphy TJ, Raymond SL, Mira JC, et al · · 2018 · cited 107× · PMID 28885387 · DOI 10.1097/shk.0000000000000981
3. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study.
   Conway Morris A, Datta D, Shankar-Hari M, Stephen J, et al · · 2018 · cited 92× · PMID 29915941 · DOI 10.1007/s00134-018-5247-0
4. A Multicenter Network Assessment of Three Inflammation Phenotypes in Pediatric Sepsis-Induced Multiple Organ Failure.
   Carcillo JA, Berg RA, Wessel D, Pollack M, et al · · 2019 · cited 74× · PMID 31568246 · DOI 10.1097/pcc.0000000000002105
5. Assessment of immune organ dysfunction in critical illness: utility of innate immune response markers.
   Pfortmueller CA, Meisel C, Fux M, Schefold JC. · · 2017 · cited 72× · PMID 29063386 · DOI 10.1186/s40635-017-0163-0
6. Sepsis and Nosocomial Infection: Patient Characteristics, Mechanisms, and Modulation.
   Denstaedt SJ, Singer BH, Standiford TJ. · · 2018 · cited 66× · PMID 30459764 · DOI 10.3389/fimmu.2018.02446
7. Targeting Neutrophils in Sepsis: From Mechanism to Translation.
   Shen X, Cao K, Zhao Y, Du J. · · 2021 · cited 64× · PMID 33912055 · DOI 10.3389/fphar.2021.644270
8. Expert consensus on the monitoring and treatment of sepsis-induced immunosuppression.
   Pei F, Yao RQ, Ren C, Bahrami S, et al · · 2022 · cited 53× · PMID 36567402 · DOI 10.1186/s40779-022-00430-y