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Micafungin does not improve infection-free survival in adults with sepsis, fungal infection
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Micafungin treatment in patients with ICU-acquired sepsis and suspected fungal infection did not improve fungal infection-free survival, researchers in France found.
“Despite the development of effective and safer drugs, invasive candidiasis and candidemia remain associated with high and increasing mortality, particularly when complicated by septic shock,” Jean-Francois Timsit, MD, PhD, of the Medical and Infectious Diseases ICU of Bichat-Claude Bernard University Hospital, Paris, and colleagues wrote. “Despite lack of evidence-based data, as much as 8% of ICU patients without documented Candida infection receive antifungal agents. To our knowledge, no randomized clinical trial of colonization-driven empirical therapy has been performed in critically ill patients at risk for invasive candidiasis.”
The Empirical Antifungal Treatment in ICUS (EMPIRICUS) study included 260 critically ill patients with ICU-acquired sepsis and multiple Candida colonization sites from 19 ICUs in France enrolled between July 2012 and February 2015. Mean age of patients was 63 years, and 65% were men. The primary endpoint was 28-day survival without invasive fungal infection, and secondary endpoints included new fungal infections, 28- and 90-day survival, organ failure, serum (1-3)-beta-D-glucan level change and ventilator-associated bacterial pneumonia.
Of 251 patients in the intent-to-treat analysis, the researchers randomly assigned 128 to micafungin and 123 to placebo. Median Sequential Organ Failure Assessment score was eight, median number of Candida-colonized sites was three and median (1-3)-beta-D-glucan level was 99 pg/mL.
Eighty-two (68%) patients in the micafungin group were alive and fungal infection-free at day 28, compared with 79 (60.2%) in the placebo group (HR = 1.35; 95% CI, 0.87-2.08), Timsit and colleagues reported. Patients with a (1-3)-beta-D-glucan level greater than 80 pg/mL had similar results (n = 175; HR = 1.41; 95% CI, 0.85-2.33). The 28-day fungal infection-free survival among patients with a high organ failure score was not significantly different between the micafungin and placebo groups (HR = 1.69; 95% CI, 0.96-2.94). Micafungin use decreased the rate of new fungal infections in four (3%) patients in the micafungin group vs. placebo (12%; P = .008).
“Although guidelines for empirical treatment of Candida and serial surveillance have been implemented, evidence supporting their use has yet to provide conclusive mortality benefits,” Trishul Siddharthan, MD, of the division of pulmonary and critical care at Johns Hopkins University School of Medicine, and colleagues wrote in an accompanying editorial. “These newer [antifungal] agents inevitably result in increased cost of care and raise concern about the potential of antifungal disease. In light of these findings, guidelines concerning empirical treatment and surveillance should be revisited.” – by Andy Polhamus
Disclosure: Timsit reports receiving personal fees from Abbott for scientific board participation; honoraria from Bayer; and lecture fees from Astellas, Gilead, Merck and Pfizer; all outside of the submitted work. Please see the full study for a complete list of all other researchers’ relevant financial disclosures. Siddharthan and colleagues report no relevant financial disclosures.
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