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
double-blind, randomized, placebo-controlled study.
Setting: ICU, multicenter.
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 μg) or placebo was
administered IV daily for up to 5 days.
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