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(Chest. 2001;119:523-529.)
© 2001 American College of Chest Physicians

Filgrastim in Patients With Pneumonia and Severe Sepsis or Septic Shock*

Richard G. Wunderink, MD, FCCP; Kenneth V. Leeper, Jr., MD; Roland Schein, MD, FCCP; Steve Nelson, MD, FCCP; Bennett P. DeBoisblanc, MD; Nick Fotheringham, PhD and Eileen Logan, MSN

* From the University of Tennessee, College of Medicine, Memphis, TN (Drs. Wunderink and Leeper); Department of Veterans Affairs Medical Center/University of Miami School of Medicine, Miami, FL (Dr. Schein); Louisiana State University Medical Center, New Orleans, LA (Drs. Nelson and DeBoisblanc); and Amgen Inc., Thousand Oaks, CA (Dr. Fotheringham and Ms. Logan).

Correspondence to: Richard G. Wunderink, MD, FCCP; Pulmonary/Critical Care Research, Methodist Healthcare Memphis, 1265 Union Ave, Suite 501 Crews, Memphis, TN 38104; e-mail: wunderir{at}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 µg) 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.

Key Words: acute physiology and chronic health evaluation II • clinical trial • filgrastim • pneumonia • sepsis • septic shock




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