title: A randomized controlled trial of granulocyte colony-stimulating factor for the treatment of severe sepsis due to melioidosis in Thailand.
abstract: BACKGROUND
  Melioidosis is a tropical infectious disease associated with significant mortality. Most deaths occur early and are caused by fulminant sepsis.
  
  
  METHODS
  In this randomized, placebo-controlled trial, we assessed the efficacy of lenograstim (granulocyte colony-stimulating factor [G-CSF], 263 mu g per day administered intravenously) in ceftazidime-treated patients with severe sepsis caused by suspected melioidosis in Thailand.
  
  
  RESULTS
  Over a 27-month period, 60 patients were enrolled to receive either G-CSF (30 patients, 18 of whom had culture-confirmed melioidosis) or placebo (30 patients, 23 of whom had culture-confirmed melioidosis). Mortality rates were similar in both groups (G-CSF group, 70%; placebo group, 87%; risk ratio, 0.81; 95% confidence interval, 0.61-1.06; P=.2), including among patients with confirmed melioidosis (83% vs. 96%; P=.3). The duration of survival was longer for patients who received G-CSF than for patients who received placebo (33 h vs. 18.6 h; hazard ratio, 0.56; 95% confidence interval, 0.31-1.00; P=.05).
  
  
  CONCLUSIONS
  Receipt of G-CSF is associated with a longer duration of survival but is not associated with a mortality benefit in patients with severe sepsis who are suspected of having melioidosis in Thailand. We hypothesize that G-CSF may "buy time" for severely septic patients, but survival is more likely to be improved by management of associated metabolic abnormalities and organ dysfunction associated with severe sepsis.
authors.affiliation: Menzies School of Health Research, Charles Darwin University, Darwin, Australia. allen.cheng@menzies.edu.au
authors.forename: Allen C
authors.initials: AC
authors.lastname: Cheng
authors.forename: Direk
authors.initials: D
authors.lastname: Limmathurotsakul
authors.forename: Wirongrong
authors.initials: W
authors.lastname: Chierakul
authors.forename: Nongluk
authors.initials: N
authors.lastname: Getchalarat
authors.forename: Vanaporn
authors.initials: V
authors.lastname: Wuthiekanun
authors.forename: Dianne P
authors.initials: DP
authors.lastname: Stephens
authors.forename: Nicholas P J
authors.initials: NP
authors.lastname: Day
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: White
authors.forename: Wipada
authors.initials: W
authors.lastname: Chaowagul
authors.forename: Bart J
authors.initials: BJ
authors.lastname: Currie
authors.forename: Sharon J
authors.initials: SJ
authors.lastname: Peacock
mesh_terms: D018806:APACHE; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D000078224:Lenograstim; D008554:Melioidosis / Q000188:drug therapy* / Q000382:microbiology* / Q000401:mortality; D010919:Placebos; D011994:Recombinant Proteins / Q000627:therapeutic use; D018805:Sepsis / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D016019:Survival Analysis; D013785:Thailand; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim