A Randomized Controlled Trial of Granulocyte Colony‐Stimulating Factor for the Treatment of Severe Sepsis Due to Melioidosis in Thailand
1Menzies School of Health Research, Charles Darwin University, and 2Royal Darwin Hospital, Darwin, Australia; 3Faculty of Tropical Medicine, Mahidol University, Bangkok, and 4Department of Medicine, Sappasithiprasong Hospital, Ubon Ratchathani, Thailand; and 5Centre for Tropical Diseases, Nuffield Department of Clinical Medicine, John Radcliffe Hospital, Oxford, United Kingdom
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 μg 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; 
), including among patients with confirmed melioidosis (83% vs. 96%; 
). 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; 
).
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.
Received 26 February 2007; accepted 18 April 2007; electronically published 15 June 2007.
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