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Filgrastim in patients with pneumonia and severe sepsis or septic shock
R Wunderink1, K Leeper, R Schein
1University of Tennessee, College of Medicine, Memphis, TN, USA. wunderir@methodisthealth.org
Study Objectives:
Evaluate the safety of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor) administration, combined with standard therapy, in patients with pneumonia and either septic shock or severe sepsis who were receiving mechanical ventilation.
Design:
Multicenter, double-blind, randomized, placebo-controlled study.
Setting:
ICU, multicenter.
Patients:
Eighteen patients with pneumonia and hypotension, or in the absence of shock, two or more end-organ dysfunctions, were enrolled and treated. Baseline acute physiology and chronic health evaluation II scores and median age for the filgrastim (n = 12) and placebo (n = 6) groups were 25.0 and 49.5 years and 31.5 and 56.5 years, respectively.
Intervention:
Filgrastim (300 microg) or placebo was administered IV daily for up to 5 days.
Measurements And Results:
Study end points included safety; biological response, including endogenous cytokine levels, endotoxin levels, and neutrophil counts; and mortality. Cytokine and endotoxin levels were highly variable in both groups. By day 29, 3 of 12 filgrastim-treated patients and 4 of 6 placebo-treated patients had died. There were no differences in types and occurrences of adverse events, including ARDS, or in outcome between the two groups. Three of four placebo-treated patients had persistent bacterial growth on bronchoscopy repeated after 48 h compared with 2 of 10 filgrastim-treated patients.
Conclusion:
Filgrastim appeared to be well tolerated in this population of patients with pneumonia and severe sepsis or septic shock. Larger studies to determine the benefit of filgrastim in patients with pneumonia and sepsis or organ dysfunction are warranted.
Insights
Filgrastim (recombinant methionyl human granulocyte colony-stimulating factor) was safe for pneumonia patients with severe sepsis or septic shock. Further research is needed to confirm filgrastim
Area of Science:
- Critical Care Medicine
- Pharmacology
- Infectious Diseases
Background:
- Severe sepsis and septic shock are life-threatening conditions often requiring mechanical ventilation.
- Pneumonia is a common cause of sepsis, leading to significant morbidity and mortality.
- Granulocyte colony-stimulating factors (G-CSFs) are investigated for their potential role in modulating the immune response during sepsis.
Purpose of the Study:
- To evaluate the safety and tolerability of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor) when added to standard therapy.
- To assess the impact of filgrastim on biological markers and mortality in critically ill patients with pneumonia and sepsis.
Main Methods:
- A multicenter, double-blind, randomized, placebo-controlled study was conducted in an intensive care unit (ICU) setting.
- Eighteen patients with pneumonia and either septic shock or severe sepsis were enrolled.
- Patients received either filgrastim (300 microg IV daily for up to 5 days) or a placebo, alongside standard treatment.
Main Results:
- Filgrastim was well-tolerated, with no significant differences in adverse events, including acute respiratory distress syndrome (ARDS), compared to placebo.
- Mortality rates at day 29 were similar between groups (3/12 in the filgrastim group vs. 4/6 in the placebo group).
- A trend towards reduced persistent bacterial growth was observed in filgrastim-treated patients.
Conclusions:
- Filgrastim appears to be safe and well-tolerated in patients with pneumonia complicated by severe sepsis or septic shock requiring mechanical ventilation.
- The study suggests a potential benefit in reducing bacterial persistence, although not statistically significant in this small cohort.
- Larger clinical trials are warranted to definitively establish the efficacy and benefit of filgrastim in this patient population.