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.
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.
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DOI：
10.1186/1471-2334-14-97
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发表时间：
2014-02-21
影响因子：
3.7
通讯作者：
Swanson R
中科院分区：
文献类型：
--
作者：
Vazquez J;Reboli AC;Pappas PG;Patterson TF;Reinhardt J;Chin-Hong P;Tobin E;Kett DH;Biswas P;Swanson R
住院患者发生念珠菌血症和侵袭性念珠菌病（C/IC）的风险增加。仍然需要利用现有的抗真菌药物改善治疗方案，提高临床和药物经济学结果。一项开放标签、非比较性研究评价了静脉（IV）至口服降压策略。C/IC患者接受静脉注射阿尼芬净治疗，如果符合预定标准，静脉注射治疗5天后可以选择改为口服唑类药物治疗（氟康唑或伏立康唑）。主要终点为改良意向治疗（MITT）人群（入组研究后96小时内至少一剂阿尼芬净+阳性念珠菌）治疗结束（EOT）时的总体缓解率（临床+微生物学）。次要终点包括其他时间点和预定义患者亚群的疗效。提前停用（阿尼芬净≤ 7天）的患者被确定为“提前转换”亚群。总共入组了282例患者，其中250例被纳入MITT人群。EOT时的MITT总体缓解率为83.7%（95%置信区间，78.7-88.8）。与MITT人群相比，早期转换亚群在所有时间点的总体缓解率通常相似。包括念珠菌在内的多种念珠菌的总体缓解率也相似。albicans、假丝酵母C. glabrata和C.近平滑最常见的治疗相关不良事件是恶心和呕吐（各4例患者）。短期静脉注射阿尼芬净，然后早期逐步减量至口服唑类药物治疗，是治疗C/IC的有效且耐受性良好的方法。ClinicalTrials.gov：NCT00496197
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. 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. 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). 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. ClinicalTrials.gov: NCT00496197
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DOI：
10.1186/cc10514
发表时间：
2011
期刊：
Critical care (London, England)
影响因子：
--
作者：
Kett DH;Shorr AF;Reboli AC;Reisman AL;Biswas P;Schlamm HT
通讯作者：
Schlamm HT
影响因子：
5.2
作者：
Sevinç, F;Prins, JM;Speelman, P
通讯作者：
Speelman, P
影响因子：
4.9
作者：
Krause, DS;Reinhardt, J;Henkel, T
通讯作者：
Henkel, T
影响因子：
11.8
作者：
Krause, DS;Simjee, AE;Henkel, T
通讯作者：
Henkel, T
影响因子：
158.5
作者：
Mora-Duarte, J;Betts, R;Perfect, J
通讯作者：
Perfect, J