NCT02361528

GM-CSF to Decrease ICU Acquired Infections

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DRUG	Sargramostim: Leukine (Genzyme USA)	Leukine: 125 µg/m² daily, subcutaneously, for 5 days.
DRUG	Placebo	placebo subcutaneously, for 5 days

Timeline

• Start date: 2015-09-14
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-02-11
• Last updated: 2025-09-03

Locations

18 sites across 1 country: France