A randomized, placebo-controlled trial of pre-emptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections.
Clin Infect Dis. 2015 Aug 13;
Authors: Knitsch W, Vincent JL, Utzolino S, François B, Dinya T, Dimopoulos G, Özgüneş İ, Valía JC, Eggimann P, León C, Montravers P, Phillips S, Tweddle L, Karas A, Brown M, Cornely OA
BACKGROUND: Patients undergoing emergency gastrointestinal surgery for intra-abdominal infection are at risk of invasive candidiasis (IC) and candidates for pre-emptive antifungal therapy.
METHODS: This exploratory, randomized, double-blind, placebo-controlled trial assessed a pre-emptive antifungal approach with micafungin 100 mg in intensive care unit (ICU) patients requiring surgery for intra-abdominal infection. Co-primary efficacy variables were IC incidence (difference [95% confidence interval, CI]) and time from baseline to first IC in the full analysis set (FAS); an independent data review board confirmed IC. An exploratory biomarker analysis was performed using logistic regression.
RESULTS: The FAS comprised 124 placebo- and 117 micafungin-treated patients. IC incidence was 8.9% and 11.1% for placebo and micafungin; difference 2.24% (95% CI, -5.52, 10.20). There was no difference between the arms in median time to IC. The estimated odds ratio showed that patients with a positive (1-3)-beta-D-glucan (ßDG) result were 3.66 (95% CI 1.01, 13.29) times more likely than those with a negative result to have confirmed IC.
CONCLUSIONS: This study was unable to provide evidence that pre-emptive administration of an echinocandin was effective in preventing IC in high-risk surgical ICU patients with intra-abdominal infections. This may have been due to administering drug too late to prevent IC coupled with an overall low number of IC events. It does provide some evidence for using ßDG to identify high-IC risk patients.
PMID: 26270686 [PubMed - as supplied by publisher]