Although itraconazole exhibits potent activity against Candida species, there have been few studies examining the use ofintravenous itraconazole in the treatment of invasive candidiasis. A nationwide multicenter clinical study was conducted toevaluate the efficacy and safety of intravenous itraconazole in the management of invasive candidiasis, includingnon-albicans Candida species, in non-neutropenic patients undergoing surgery and critical care. Between September 2007 andAugust 2009, patients with proven and presumed candidiasis were enrolled at 22 participating institutions. Patients withpresumed candidiasis had a deep-body temperature of 37.8°C or higher and were positive for serum β-d-glucan or twoor more colonization sites of Candida species. The main exclusion criterion was severe renal impairment (creatinine clearance<30 ml/min). The primary efficacy analysis was based on clinical and microbiological responses 5-10 days after the end oftreatment, assessed by an independent data review committee. Of the 60 patients enrolled, 49 were included in the modifiedintention-to-treat population; 31 patients received a definitive diagnosis and 18 patients a presumed diagnosis. Intravenousitraconazole was used as first-line therapy to treat 39 patients and as second-line therapy for 10 patients. The isolatedspecies included Candida albicans (25 strains with definitive diagnosis and 17 with presumed diagnosis) and non-albicansspecies (16 and 10, respectively). Treatment was successful in 61.5% patients (65.5% in first-line and 50.0% in second-linetherapy); 60% of proven invasive candidiasis (IC) patients were judged as successful compared with 63.2% of presumedcandidiasis patients. Eradication rate was 63.6% for C. albicans and 71.4% for C. glabrata. Adverse effects occurred in 9 of60 patients (15.0%), commonly impaired liver function. The clinical efficacy and safety of intravenous itraconazole weresuggested in the management of proven and presumed candidiasis including C. glabrata in non-neutropenic patients. The statusof intravenous itraconazole in the Japanese guideline warrants reconsideration.
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