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侵袭性曲霉病的优效性试验：IA-DUET（HOVON502）试验的严峻现实检验

Superiority Trials in Invasive Aspergillosis: A Harsh Reality Check With the IA-DUET (HOVON502) Trial.

作者信息

Lamberink Hanne, Huygens Sammy, Aerts Robina, Lagrou Katrien, van Leeuwen-Segarceanu Elena, Lodewyck Tom, Nieuwenhuizen Laurens, Corsten Maarten F, Moors Ine, Servais Sophie, De Greef Julien, Hites Maya, Demandt Astrid, Schauwvlieghe Alexander, Maertens Johan, Rijnders Bart

机构信息

Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.

Department of Hematology, Ghent University Hospital, Ghent, Belgium.

出版信息

Clin Infect Dis. 2025 Feb 24;80(2):367-370. doi: 10.1093/cid/ciae501.

DOI:10.1093/cid/ciae501
PMID:39378343
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11848251/
Abstract

The IA-DUET study aimed to compare azole-echinocandin combination therapy with azole monotherapy for invasive aspergillosis. Recruitment was hindered by patient ineligibility, competing studies, and guidelines favoring combination therapy when azole resistance was unknown. The low IA-attributable mortality suggests future trials may benefit from cluster randomization or composite endpoints to enhance efficiency.

摘要

IA-DUET研究旨在比较唑类药物与棘白菌素联合治疗和唑类药物单药治疗侵袭性曲霉病的效果。患者不符合入选标准、存在竞争性研究以及在唑类药物耐药情况不明时指南倾向于联合治疗，这些因素阻碍了研究招募。侵袭性曲霉病所致的低死亡率表明，未来的试验可能会从整群随机化或复合终点中受益，以提高效率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7092/11848251/d911075e2fd4/ciae501f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7092/11848251/d911075e2fd4/ciae501f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7092/11848251/d911075e2fd4/ciae501f1.jpg

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Med Mycol. 2024 Jun 27;62(6). doi: 10.1093/mmy/myad129.
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Meeting the Therapeutic Challenges of Emergent and Rare Invasive Fungal Diseases Through Novel Clinical Trial Designs.通过新型临床试验设计应对紧急和罕见侵袭性真菌病的治疗挑战。
Open Forum Infect Dis. 2024 Jun 17;11(6):ofae257. doi: 10.1093/ofid/ofae257. eCollection 2024 Jun.
3
Implementation of a clinical decision rule for selecting empiric treatment for invasive aspergillosis in a setting with high triazole resistance.
在三唑类药物耐药率较高的环境中实施一项用于选择侵袭性曲霉菌病经验性治疗的临床决策规则。
Med Mycol. 2021 Dec 8;60(1). doi: 10.1093/mmy/myab060.
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Review of influenza-associated pulmonary aspergillosis in ICU patients and proposal for a case definition: an expert opinion.重症监护病房患者流感相关肺曲霉病综述及病例定义建议：专家意见
Intensive Care Med. 2020 Aug;46(8):1524-1535. doi: 10.1007/s00134-020-06091-6. Epub 2020 Jun 22.
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Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium.侵袭性真菌病的共识定义修订与更新：来自欧洲癌症研究与治疗组织和真菌病研究组教育与研究联合会。
Clin Infect Dis. 2020 Sep 12;71(6):1367-1376. doi: 10.1093/cid/ciz1008.
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