Abstract
IntroductionDuring the past decade, the incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections. However, the 2009 Infectious Diseases Society of America (IDSA) candidiasis guidelines recommend an echinocandin for the treatment of candidemia/invasive candidiasis in patients who are considered to be "moderately severe or severely" ill. To validate these guidelines, clinical trial data were reviewed.MethodsA secondary analysis of data from a previously published prospective, randomized, double-blind clinical trial was performed; it compared anidulafungin with fluconazole for the treatment of invasive candidiasis and candidemia. Patients with critical illness were identified at study entry by using the following criteria: Acute Physiology and Chronic Health Evaluation (APACHE) II score of ≥ 15, evidence of severe sepsis (sepsis and one or more end-organ dysfunctions) present, and/or patient was in intensive care. Global response rates were compared at the end of intravenous study treatment (the primary end point of the original study) and all-cause mortality at 14 and 28 days from study entry in this group.ResultsThe patients (163 (66.5%) of 245) fulfilled at least one criterion for critical illness (anidulafungin, n = 89; fluconazole, n = 74). No significant differences were found in baseline characteristics between the two treatment groups. The global response rate was 70.8% for anidulafungin and 54.1% for fluconazole (P = 0.03; 95% confidence interval (CI): 2.0 to 31.5); all-cause mortality was 10.1% versus 20.3% at 14 days (P = 0.08; 95% CI, -0.9 to 21.3) and was 20.2% versus 24.3% at 28 days (P = 0.57; 95% CI, -8.8 to 17.0) for anidulafungin and fluconazole, respectively.ConclusionsIn this post hoc analysis, anidulafungin was more effective than fluconazole for treatment of severely ill patients with candidemia, thus supporting the 2009 IDSA guidelines.Trial registrationClinicaltrials.gov NCT00058682.
Highlights
During the past decade, the incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections
The 2009 Infectious Diseases Society of America (IDSA) treatment guidelines favor an echinocandin as initial therapy for candidemia in patients with “moderately severe to severe” illness, with fluconazole reserved for patients who are less severely ill [18]
Global response at the end of treatment was significantly higher with anidulafungin than with fluconazole (68.3% versus 46.0%; P < 0.05; 95% confidence interval (CI), 4.3 to 40.2) (Table 2 and Figure 1)
Summary
The incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections. The 2009 Infectious Diseases Society of America (IDSA) candidiasis guidelines recommend an echinocandin for the treatment of candidemia/invasive candidiasis in patients who are considered to be “moderately severe or severely” ill. To validate these guidelines, clinical trial data were reviewed. Based on a review of the distribution of baseline Acute Physiology and Chronic Health Evaluation (APACHE) II scores in this study [23], we suspected that a substantial proportion of patients would be considered severely ill at study entry We saw this as an opportunity to compare outcomes in these patients, allowing us to validate the 2009 IDSA candidemia treatment guidelines
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