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: Allen C Cheng, Direk Limmathurotsakul, Wirongrong Chierakul, Nongluk Getchalarat, Vanaporn Wuthiekanun, Dianne P Stephens, Nicholas P J Day, Nicholas J White, Wipada Chaowagul, Bart J Currie, Sharon J Peacock
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 45 Issue 3 Pg. 308-14 (Aug 01 2007) ISSN: 1537-6591 [Electronic] United States
• PMID: 17599307 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Lenograstim

Topics

• APACHE
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Lenograstim
• Melioidosis (drug therapy, microbiology, mortality)
• Placebos
• Recombinant Proteins (therapeutic use)
• Sepsis (drug therapy, etiology, mortality)
• Survival Analysis
• Thailand
• Treatment Outcome