■2020年更新了侵袭性真菌病(IFD)诊断的共识定义,以提高IFD纳入临床试验的确定性。例如,通过增加生物标志物的截止限值来定义阳性。迄今为止,关于修订后的定义对临床试验的影响的数据很少.
■在这项研究中,我们试图确定新定义对侵袭性曲霉病(IA)分类的影响,免疫功能低下患者中最常见的侵袭性霉菌病。我们使用新标准对曲霉技术联盟(AsTeC)和抗真菌预防试验(BMTCTN0101)中的226例已证实和可能的IA病例以及139例可能的IFD病例进行了重新分类。
■在应用重新分类标准来定义可能的IA后,更少的病例符合更严格的2020年诊断标准。在188个可评估的可能病例中,41(22%)被重新分类为40个可能的IA和1个可能的IFD。22%的血液系统恶性肿瘤(HM)患者发生了可能的IFD的重新分类,29%的造血细胞移植(HCT)患者,和没有肺移植(LT)的患者。使用新标准,在15%的可能IA病例中,诊断日期的中位数(范围)为3(1-105)天。将新定义应用于BMTCTN0101试验,检测相同比值比的能力大幅下降。
■更新的IA共识定义可能会影响未来的试验设计,尤其是抗真菌预防研究。
UNASSIGNED: Consensus definitions for the diagnosis of invasive fungal diseases (IFDs) were updated in 2020 to increase the certainty of IFD for inclusion in clinical trials, for instance by increasing biomarker cutoff limits to define positivity. To date, there is a paucity of data as to the impact of the revised definitions on clinical trials.
UNASSIGNED: In this study, we sought to determine the impact of the new definitions on classifying invasive aspergillosis (IA), the most common invasive mold disease in immunocompromised patients. We reclassified 226 proven and probable IA cases plus 139 possible IFD cases in the Aspergillus Technology Consortium (AsTeC) and in an antifungal prophylaxis trial (BMT CTN 0101) using the new criteria.
UNASSIGNED: Fewer cases met the more stringent diagnostic 2020 criteria after applying the reclassification criteria to define probable IA. Of 188 evaluable probable cases, 41 (22%) were reclassified to 40 possible IA and 1 probable IFD. Reclassification to possible IFD occurred in 22% of hematologic malignancy (HM) patients, 29% of hematopoietic cell transplant (HCT) patients, and in no lung transplant (LT) patients. Date of diagnosis was established a median (range) of 3 (1-105) days later in 15% of probable IA cases using the new criteria. Applying the new definitions to the BMT CTN 0101 trial, the power to detect the same odds ratio decreased substantially.
UNASSIGNED: The updated IA
consensus definitions may impact future trial designs, especially for antifungal prophylaxis studies.