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
{"title":"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。","authors":"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","doi":"10.1016/j.cmi.2024.11.029","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>A post hoc analysis used pooled STRIVE/ReSTORE trial data to determine outcomes with rezafungin versus caspofungin by Candida species and antifungal susceptibility.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Rezafungin appears to be an effective treatment for candidaemia/invasive candidiasis irrespective of baseline Candida species.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9000,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"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\",\"doi\":\"10.1016/j.cmi.2024.11.029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>A post hoc analysis used pooled STRIVE/ReSTORE trial data to determine outcomes with rezafungin versus caspofungin by Candida species and antifungal susceptibility.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Rezafungin appears to be an effective treatment for candidaemia/invasive candidiasis irrespective of baseline Candida species.</p>\",\"PeriodicalId\":10444,\"journal\":{\"name\":\"Clinical Microbiology and Infection\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":10.9000,\"publicationDate\":\"2024-11-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Microbiology and Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cmi.2024.11.029\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology and Infection","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cmi.2024.11.029","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
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.
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.
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.
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