title: A randomized controlled trial of filgrastim for the treatment of hospitalized patients with multilobar pneumonia.
abstract: This study assessed the safety and efficacy of filgrastim (r-metHuG-CSF [recombinant human methionine granulocyte colony-stimulating factor]), when combined with intravenous (IV) antibiotics, in the treatment of hospitalized adult patients with multilobar community-acquired pneumonia (CAP). Four hundred eighty patients were randomized to receive placebo (n=243) or filgrastim 300 microg/day (n=237), in addition to standard therapy. Treatment with study drug was continued for 10 days, until the peak white blood cell (WBC) count reached 75x109/L, until discharge from the hospital, until death, or until IV antibiotics were discontinued. Study-related observations continued through day 29. Filgrastim increased WBC counts (baseline median, 13.3x109/L; median peak, 43. 8x109/L). The 2 treatment groups were not statistically different with respect to the study end points; however, there was a trend toward reduction of mortality in patients with pneumococcal bacteremia. Although further studies will be required to validate this observation, filgrastim was safe and well tolerated when administered to patients with multilobar CAP.
authors.affiliation: Louisiana State University Health Sciences Center, New Orleans, LA 70112, USA. snelso1@lsumc.edu
authors.forename: S
authors.initials: S
authors.lastname: Nelson
authors.forename: A M
authors.initials: AM
authors.lastname: Heyder
authors.forename: J
authors.initials: J
authors.lastname: Stone
authors.forename: M G
authors.initials: MG
authors.lastname: Bergeron
authors.forename: S
authors.initials: S
authors.lastname: Daugherty
authors.forename: G
authors.initials: G
authors.lastname: Peterson
authors.forename: N
authors.initials: N
authors.lastname: Fotheringham
authors.forename: W
authors.initials: W
authors.lastname: Welch
authors.forename: S
authors.initials: S
authors.lastname: Milwee
authors.forename: R
authors.initials: R
authors.lastname: Root
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D011994:Recombinant Proteins; D013296:Streptococcus pneumoniae
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim