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Antifungal therapy fails to prevent invasive candidiasis after surgery for intra-abdominal infection
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Antifungal therapy was not effective in preemptively treating patients who underwent emergency gastrointestinal surgery for intra-abdominal infections while at high risk for invasive candidiasis, according to recent results from an exploratory, randomized, double blind, placebo-controlled trial published in Clinical Infectious Diseases.
“The INTENSE study did not provide evidence to support the use of a preemptive antifungal strategy in high-risk surgical patients with intra-abdominal infections,” Wolfgang Knitsch, MD, from the Department of Visceral Surgery at Hannover Medical School in Hannover, Germany, and colleagues wrote.
ICU patients requiring surgery for either community-acquired or nosocomial-acquired intra-abdominal infections were randomly assigned to placebo (n = 124) or 100 mg of Mycamine (micafungin, Astellas) (n = 117). Patients with nosocomial-acquired infections received treatment 48 hours postoperatively, while patients with community-acquired infections received treatment within 72 hours and 120 hours postoperatively. Confirmation of invasive candidiasis was made at baseline, during treatment, the end of treatment and at the end of study.
Knitsch and colleagues found 8.9% of patients in the placebo group and 11.1% of patients in the micafungin group had confirmed invasive candidiasis in the full analysis set, with a 2.24% difference (95% CI, -5.52 to 10.2).
“The incidence of 11.1% in the micafungin arm was unexpected,” the researchers said. “As micafungin is an effective treatment for candidemia and [invasive candidiasis], this suggests [invasive candidiasis] might have been established in these patients and preemptive therapy was administered too late.”
There was no significant difference in median time to invasive candidiasis in either group. Patients with a positive beta-D-glucan biomarker were 3.66 times more likely to have confirmed invasive candidiasis (95% CI 1.01-13.29), according to Knitsch and colleagues.
Taken with previous findings, these study results “highlight the challenge of demonstrating the benefit of administering an antifungal in the absence of proven [invasive candidiasis] even in ICU patient populations that have multiple risk factors for [invasive candidiasis],” the researchers wrote. – by Jeff Craven
Disclosure: Knitsch is a consultant for Astellas Pharma, Gilead Sciences, Merck, Novartis and Pfizer. Please see the full study for list of all other authors’ relevant financial disclosures.
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