A randomized, placebo-controlled study of the use of filgrastim in non neutropenic patients with nosocomial pneumonia.
Pneumonia remains the number one cause of death from infectious diseases in Western Europe and the United States despite the introduction of potent broad-spectrum antibiotics. Granulocyte colony-stimulating factor is considered to improve host defense during infection and may be an effective adjunctive in the treatment of severe infections. We examined the efficacy of granulocyte colony-stimulating factor (r-metHUG-CSF, filgrastim) with regard to clinical response in non-neutropenic ICU patients with nosocomial pneumonia in a prospective, randomized, placebo-controlled trial. 28 patients with newly diagnosed nosocomial pneumonia were randomly assigned to receive 300-480 microg filgrastim or placebo subcutaneously for up to seven days. Study endpoints were death within 15 days, duration of antibiotic therapy and occurrence of serious adverse events (SAE). No significant differences were observed in respect of 15-day (filgrastim1/12 vs. placebo 2/16) or 30-day mortality (1/12 vs.4/16, p=0.355), and length of antibiotic treatment (13.5 vs.11.5 days, p=0.985). Sepsis developed in 1/12 patients in the filgrastim and 6/16 patients in the placebo group (p=0.184). None of the patients developed ARDS or any other SAE related to the study medication. Filgrastim is safe in non-neutropenic ICU patients with nosocomial pneumonia. A benefit of filgrastim with regard to clinical endpoints could not be observed, while there was a trend toward reduced sepsis rate.
Hartmann
Pia
P
Department of Internal Medicine I, Division of Infectious Diseases, D-93042 Regensburg, Germany. pia.hartmann@klinik.uni-regensburg.de
Lammertink
J
J
Mansmann
G
G
Hübel
K
K
Salzberger
B
B
Stützer
H
H
Engert
A
A
Fätkenheuer
G
G
D000328:Adult; D000368:Aged; D003428:Cross Infection / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000150:complications; D011014:Pneumonia / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D011994:Recombinant Proteins; D015996:Survival Rate
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim