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Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials
Critical Care ( IF 8.8 ) Pub Date : 2024-11-11 , DOI: 10.1186/s13054-024-05152-2 Patrick M. Honoré, Matteo Bassetti, Oliver A. Cornely, Herve Dupont, Jesús Fortún, Marin H. Kollef, Peter Pappas, John Pullman, Jose Vazquez, Inga Bielicka, Sara Dickerson, Nick Manamley, Taylor Sandison, George R. Thompson
Critical Care ( IF 8.8 ) Pub Date : 2024-11-11 , DOI: 10.1186/s13054-024-05152-2 Patrick M. Honoré, Matteo Bassetti, Oliver A. Cornely, Herve Dupont, Jesús Fortún, Marin H. Kollef, Peter Pappas, John Pullman, Jose Vazquez, Inga Bielicka, Sara Dickerson, Nick Manamley, Taylor Sandison, George R. Thompson
Invasive candidiasis/candidemia (IC/C) is associated with a substantial health economic burden driven primarily by prolonged hospital stay. The once-weekly IV echinocandin, rezafungin acetate, has demonstrated non-inferiority to caspofungin in the treatment of IC/C. This paper reports a post hoc pooled exploratory analysis of length of stay (LoS) for hospital and intensive care unit (ICU) stays in two previously published clinical trials (ReSTORE [NCT03667690] and STRIVE [NCT02734862], that compared rezafungin with daily IV caspofungin (stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more). LoS outcomes were analysed descriptively in the pooled modified intention to treat (mITT) population (all patients who had a documented Candida infection in line with trial requirements and received at least one dose of study drug). In addition, to adjust for an imbalance between treatment groups in the proportion receiving mechanical ventilation at baseline, a generalised linear model with mechanical ventilation as a binary covariate was applied. Responses to an exploratory question in the phase 3 trial on possible earlier discharge with weekly rezafungin are also reported. 294 patients were included (rezafungin 139, caspofungin 155), of whom 126 (43%) had ICU admission. Patients treated with rezafungin had a numerically shorter LoS than with caspofungin in all analyses. Mean total LoS was 25.2 days, vs 28.3 days with caspofungin, and mean ICU LoS was 16.1 vs 21.6 days for rezafungin and caspofungin, respectively. After adjustment for mechanical ventilation status the difference in ICU LoS was 4.1 days, a relative difference of 24% (95% CI -11%, 72%). Physicians would have considered earlier discharge for 16% of patients (30/187) with weekly rezafungin, an average of 5–6 days earlier. Rezafungin may enable shorter hospital and ICU LoS in IC/C compared with daily IV caspofungin, with accompanying savings in resource use. Further research is needed to confirm this in the real-world setting. Trial registration. NCT03667690 (ReSTORE; September 12, 2018); NCT02734862 (STRIVE; April 12, 2016).
中文翻译:
接受瑞扎芬净治疗的侵袭性念珠菌病和/或念珠菌血症患者的住院时间和重症监护病房住院时间:两项随机对照试验的汇总分析
侵袭性念珠菌病/念珠菌血症 (IC/C) 与主要由住院时间延长导致的巨大健康经济负担有关。每周一次静脉注射棘白菌素醋酸瑞扎芬净已证明在治疗 IC/C 方面不劣于卡泊芬净。本文报告了先前发表的两项临床试验 (ReSTORE [NCT03667690] 和 STRIVE [NCT02734862] 中对住院和重症监护病房 (ICU) 住院时间 (LoS) 的事后汇总探索性分析,这些试验将瑞扎芬净与每日静脉注射卡泊芬净进行了比较(卡泊芬净组中符合相关标准的稳定患者可以在 3 天或更长时间后降级为氟康唑)。在合并改良意向治疗 (mITT) 人群(所有根据试验要求有记录的念珠菌感染并接受至少一剂研究药物的患者)中对 LoS 结局进行描述性分析。此外,为了调整治疗组之间在基线时接受机械通气的比例的不平衡,应用了以机械通气为二元协变量的广义线性模型。还报告了对 3 期试验中关于每周瑞扎芬净可能提前出院的探索性问题的回答。纳入 294 例患者 (rezafungin 139, caspofungin 155),其中 126 例 (43%) 入住 ICU。在所有分析中,接受 rezafungin 治疗的患者的 LoS 数值均短于卡泊芬净。平均总 LoS 为 25.2 天,卡泊芬净为 28.3 天,瑞扎芬净和卡泊芬净的平均 ICU LoS 分别为 16.1 天和 21.6 天。调整机械通气状态后,ICU LoS 的差异为 4.1 天,相对差异为 24% (95% CI -11%,72%)。 医生会考虑每周使用瑞扎芬净的 16% (30/187) 患者提前出院,平均提前 5-6 天。与每日静脉注射卡泊芬净相比,Rezafungin 可以缩短 IC/C 的医院和 ICU LoS,同时节省资源使用。需要进一步的研究才能在现实世界中证实这一点。试用注册。NCT03667690 (ReSTORE;2018 年 9 月 12 日);NCT02734862 (STRIVE;2016 年 4 月 12 日)。
更新日期:2024-11-11
中文翻译:
接受瑞扎芬净治疗的侵袭性念珠菌病和/或念珠菌血症患者的住院时间和重症监护病房住院时间:两项随机对照试验的汇总分析
侵袭性念珠菌病/念珠菌血症 (IC/C) 与主要由住院时间延长导致的巨大健康经济负担有关。每周一次静脉注射棘白菌素醋酸瑞扎芬净已证明在治疗 IC/C 方面不劣于卡泊芬净。本文报告了先前发表的两项临床试验 (ReSTORE [NCT03667690] 和 STRIVE [NCT02734862] 中对住院和重症监护病房 (ICU) 住院时间 (LoS) 的事后汇总探索性分析,这些试验将瑞扎芬净与每日静脉注射卡泊芬净进行了比较(卡泊芬净组中符合相关标准的稳定患者可以在 3 天或更长时间后降级为氟康唑)。在合并改良意向治疗 (mITT) 人群(所有根据试验要求有记录的念珠菌感染并接受至少一剂研究药物的患者)中对 LoS 结局进行描述性分析。此外,为了调整治疗组之间在基线时接受机械通气的比例的不平衡,应用了以机械通气为二元协变量的广义线性模型。还报告了对 3 期试验中关于每周瑞扎芬净可能提前出院的探索性问题的回答。纳入 294 例患者 (rezafungin 139, caspofungin 155),其中 126 例 (43%) 入住 ICU。在所有分析中,接受 rezafungin 治疗的患者的 LoS 数值均短于卡泊芬净。平均总 LoS 为 25.2 天,卡泊芬净为 28.3 天,瑞扎芬净和卡泊芬净的平均 ICU LoS 分别为 16.1 天和 21.6 天。调整机械通气状态后,ICU LoS 的差异为 4.1 天,相对差异为 24% (95% CI -11%,72%)。 医生会考虑每周使用瑞扎芬净的 16% (30/187) 患者提前出院,平均提前 5-6 天。与每日静脉注射卡泊芬净相比,Rezafungin 可以缩短 IC/C 的医院和 ICU LoS,同时节省资源使用。需要进一步的研究才能在现实世界中证实这一点。试用注册。NCT03667690 (ReSTORE;2018 年 9 月 12 日);NCT02734862 (STRIVE;2016 年 4 月 12 日)。