Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial

BMC Infectious Diseases

Robert Swanson⁶  Pinaki Biswas⁶  Daniel H Kett¹  Ellis Tobin⁹  Peter Chin-Hong³  John Reinhardt⁴  Thomas F Patterson⁷  Peter G Pappas⁵  Annette C Reboli⁸  Jose Vazquez² 

[1] University of Miami Miller School of Medicine and Jackson Memorial Hospital, Miami, FL, USA;Georgia Regents University, Augusta, GA, USA;University of California San Francisco, San Francisco, CA, USA;Christiana Care Health Services, Newark, DE, USA;University of Alabama at Birmingham, Birmingham, AL, USA;Pfizer Inc, New York, NY, USA;University of Texas and South Texas Veterans Health Care System, San Antonio, TX, USA;Cooper Medical School of Rowan University, Camden, NJ, USA;Albany Medical Center, Albany, NY, USA

关键词: Step-down strategy;    Candidemia;    Azole;    Anidulafungin;   

Others  :  1134539
DOI  :  10.1186/1471-2334-14-97

 received in 2013-04-11, accepted in 2014-02-13,  发布年份 2014

【 摘 要 】

Background

Hospitalized patients are at increased risk for candidemia and invasive candidiasis (C/IC). Improved therapeutic regimens with enhanced clinical and pharmacoeconomic outcomes utilizing existing antifungal agents are still needed.

Methods

An open-label, non-comparative study evaluated an intravenous (IV) to oral step-down strategy. Patients with C/IC were treated with IV anidulafungin and after 5 days of IV therapy had the option to step-down to oral azole therapy (fluconazole or voriconazole) if they met prespecified criteria. The primary endpoint was the global response rate (clinical + microbiological) at end of treatment (EOT) in the modified intent-to-treat (MITT) population (at least one dose of anidulafungin plus positive Candida within 96 hours of study entry). Secondary endpoints included efficacy at other time points and in predefined patient subpopulations. Patients who stepped down early (≤ 7 days’ anidulafungin) were identified as the "early switch" subpopulation.

Results

In total, 282 patients were enrolled, of whom 250 were included in the MITT population. The MITT global response rate at EOT was 83.7% (95% confidence interval, 78.7–88.8). Global response rates at all time points were generally similar in the early switch subpopulation compared with the MITT population. Global response rates were also similar across multiple Candida species, including C. albicans, C. glabrata, and C. parapsilosis. The most common treatment-related adverse events were nausea and vomiting (four patients each).

Conclusions

A short course of IV anidulafungin, followed by early step-down to oral azole therapy, is an effective and well-tolerated approach for the treatment of C/IC.

Trial registration

ClinicalTrials.gov:NCT00496197

【 授权许可】

   
2014 Vazquez et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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