A randomized controlled trial of filgrastim for the treatment of hospitalized patients with multilobar pneumonia

This study assessed the safety and efficacy of filgrastim (r-metHuG-CSF [re combinant human methionine granulocyte colony-stimulating factor]), when co mbined with intravenous (IV) antibiotics, in the treatment of hospitalized adult patients with multilobar community-acquired pneumonia (CAP), Four hun dred eighty patients were randomized to receive placebo (n = 243) or filgra stim 300 mu g/day (n = 237), in addition to standard therapy. Treatment wit h study drug was continued for 10 days, until the peak white blood cell (WB C) count reached 75 x 10(9)/L, until discharge from the hospital, until dea th, or until IV antibiotics were discontinued. Study-related observations c ontinued through day 29. Filgrastim increased WBC counts (baseline median, 13.3 x 10(9)/L; median peak, 43.8 x 10(9)/L), The 2 treatment groups were n ot statistically different with respect to the study end points; however, t here was a trend toward reduction of mortality in patients with pneumococca l bacteremia, Although further studies will be required to validate this ob servation, filgrastim was safe and well tolerated when administered to pati ents with multilobar CAP.