Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011;15(5):R253.
doi: 10.1186/cc10514. Epub 2011 Oct 25.

Anidulafungin Compared With Fluconazole in Severely Ill Patients With Candidemia and Other Forms of Invasive Candidiasis: Support for the 2009 IDSA Treatment Guidelines for Candidiasis

Affiliations
Free PMC article
Randomized Controlled Trial

Anidulafungin Compared With Fluconazole in Severely Ill Patients With Candidemia and Other Forms of Invasive Candidiasis: Support for the 2009 IDSA Treatment Guidelines for Candidiasis

Daniel H Kett et al. Crit Care. .
Free PMC article

Abstract

Introduction: 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. 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.

Methods: A 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.

Results: The 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.

Conclusions: In 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 registration: Clinicaltrials.gov NCT00058682.

Figures

Figure 1
Figure 1
Difference in global response at end of treatment among severely ill patients and the various subpopulations.
Figure 2
Figure 2
Kaplan-Meier analysis of survival to 14 days among severely ill patients with candidemia.

Comment in

Similar articles

See all similar articles

Cited by 21 articles

See all "Cited by" articles

References

    1. Eggimann P, Garbino J, Pittet D. Epidemiology of Candida species infections in critically ill non-immunosuppressed patients. Lancet Infect Dis. 2003;3:685–702. doi: 10.1016/S1473-3099(03)00801-6. - DOI - PubMed
    1. Horn DL, Fishman JA, Steinbach WJ, Anaissie EJ, Marr KA, Olyaei AJ, Pfaller MA, Weiss MA, Webster KM, Neofytos D. Presentation of the PATH Alliance registry for prospective data collection and analysis of the epidemiology, therapy, and outcomes of invasive fungal infections. Diagn Microbiol Infect Dis. 2007;59:407–414. doi: 10.1016/j.diagmicrobio.2007.06.008. - DOI - PubMed
    1. Kullberg BJ, Oude Lashof AM. Epidemiology of opportunistic invasive mycoses. Eur J Med Res. 2002;7:183–191. - PubMed
    1. Lipsett PA. Surgical critical care: fungal infections in surgical patients. Crit Care Med. 2006;34:S215–S224. doi: 10.1097/01.CCM.0000231883.93001.E0. - DOI - PubMed
    1. Richardson MD. Changing patterns and trends in systemic fungal infections. J Antimicrob Chemother. 2005;56(Suppl 1):i5–i11. - PubMed

Publication types

MeSH terms

Associated data

Feedback