Clinical and mycological outcomes of candidaemia and/or invasive candidiasis by Candida spp. and antifungal susceptibility: pooled analyses of two randomised trials of rezafungin versus caspofungin.

IF 10.9 1区医学 Q1 INFECTIOUS DISEASES

Clinical Microbiology and Infection Pub Date : 2024-11-22 DOI:10.1016/j.cmi.2024.11.029

Alex Soriano, Jeffrey B Locke, Oliver A Cornely, Emmanuel Roilides, Antonio Ramos-Martinez, Patrick M Honoré, Mariana Castanheira, Cecilia G Carvalhaes, Saad Nseir, Matteo Bassetti, Nick Manamley, Taylor Sandison, Maiken C Arendrup

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引用次数: 0

Abstract

Objectives: A post hoc analysis used pooled STRIVE/ReSTORE trial data to determine outcomes with rezafungin versus caspofungin by Candida species and antifungal susceptibility.

Methods: The efficacy and safety of once-weekly rezafungin 400/200 mg versus once-daily caspofungin 70/50 mg was demonstrated in the randomised, double-blind Phase 2 STRIVE (NCT02734862) and Phase 3 ReSTORE (NCT03667690) trials involving adults with candidaemia and/or invasive candidiasis. In this analysis, data were pooled for patients with a documented Candida infection within 96 hours of randomization who also received ≥1 dose of study drug. Treatment outcomes were evaluated by Candida species and baseline minimum inhibitory concentrations (MICs). Susceptibility was determined using EUCAST E.Def 7.4 broth microdilution methodology, with Tween 20-supplemented medium for rezafungin.

Results: 294 patients were included (rezafungin: N=139, caspofungin: N=155). Susceptibility testing at baseline identified three rezafungin non-susceptible isolates. Day 14 global cure rates were numerically similar between groups for C. albicans (rezafungin: 61.0% [36/59], caspofungin: 65.2% [45/69]) and C. tropicalis (rezafungin: 70.4% [19/27], caspofungin: 63.6% [14/22]), but higher with rezafungin than caspofungin for C. glabrata (rezafungin: 71.1% [27/38%], caspofungin: 60.0% [21/35]) and C. parapsilosis (rezafungin: 78.6% [11/44], caspofungin: 55.6% [15/27]). Day 30 all-cause mortality (ACM) rates were numerically similar between groups for C. albicans (rezafungin: 22.0% [13/59], caspofungin: 18.8% [13/69]) and C. glabrata (rezafungin: 15.8% [6/38], caspofungin: 11.4% [4/35]), but higher with caspofungin than rezafungin for C. tropicalis (rezafungin: 18.5% [5/27], caspofungin: 31.8% [2/22]) and C. parapsilosis (rezafungin: 7.1% [1/14], caspofungin: 29.6% [8/27]). Day 5/14 mycological eradication rates were numerically similar between treatments for C. albicans and C. parapsilosis, but higher with rezafungin for C. glabrata and C. tropicalis. Outcomes by Candida species were not associated with treatment-specific MICs.

Conclusions: Rezafungin appears to be an effective treatment for candidaemia/invasive candidiasis irrespective of baseline Candida species.

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念珠菌血症和/或由念珠菌属引起的侵袭性念珠菌病的临床和真菌学结果以及抗真菌药敏性：雷沙芬净与卡泊芬净两项随机试验的汇总分析。

目的：利用 STRIVE/ReSTORE 试验的汇总数据进行事后分析，根据念珠菌种类和抗真菌药敏性确定雷沙芬净与卡泊芬净的疗效：利用汇集的STRIVE/ReSTORE试验数据进行事后分析，按念珠菌种类和抗真菌药敏性确定雷沙芬净与卡泊芬净的疗效：在随机、双盲的2期STRIVE（NCT02734862）和3期ReSTORE（NCT03667690）试验中，每周一次的雷沙芬净400/200毫克与每天一次的卡泊芬净70/50毫克的疗效和安全性得到了证实，这两项试验均涉及念珠菌血症和/或侵袭性念珠菌病成人患者。在本分析中，对随机分组后 96 小时内有记录的念珠菌感染且接受了≥1 剂研究药物的患者进行了数据汇总。治疗结果按念珠菌种类和基线最低抑菌浓度 (MIC) 进行评估。结果：共纳入 294 例患者（雷沙芬净：139 例，卡泊芬净：155 例）。基线药敏试验发现了三种对雷扎芬净不敏感的分离株。对于白僵菌（雷沙芬净：61.0% [36/59]，卡泊芬净：65.2% [45/69]）和热带僵菌（雷沙芬净：70.4% [19/27]，卡泊芬净：63.6%[14/22]），但在革兰氏阴性杆菌（雷沙芬净：71.1%[27/38%]，卡泊芬净：60.0%[21/35]）和副丝状菌（雷沙芬净：78.6%[11/44]，卡泊芬净：55.6%[15/27]）方面，雷沙芬净的疗效高于卡泊芬净。白僵菌（雷沙芬净：22.0% [13/59]，卡泊芬净：18.8% [13/69]）和革兰氏菌（雷沙芬净：15.8% [6/38]，卡泊芬净：11.4%[4/35]），但在热带真菌（雷沙芬净：18.5%[5/27]，卡泊芬净：31.8%[2/22]）和副丝状菌（雷沙芬净：7.1%[1/14]，卡泊芬净：29.6%[8/27]）方面，卡泊芬净的疗效高于雷沙芬净。对白念珠菌和副丝状念珠菌来说，第5/14天的霉菌学根除率在数量上与不同治疗方法相似，但雷扎芬净对格氏念珠菌和热带念珠菌的根除率较高。按念珠菌种类划分的结果与治疗特异性 MICs 无关：无论基线念珠菌种类如何，雷沙芬净似乎都是治疗念珠菌血症/侵袭性念珠菌病的有效药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Microbiology and Infection 医学-传染病学

CiteScore

25.30

自引率

2.10%

发文量

441

审稿时长

2-4 weeks

期刊介绍： Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.