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Applying Desirability of Outcome Ranking End Point to Randomized Trial of Sulopenem for the Treatment of Complicated Urinary Tract Infections.

作者信息

Dunne Michael W, Aronin Steven I, Das Anita F, Gupta Jayanti, Akinapelli Karthik, Breen Jeanne, Zelasky Michael T, Puttagunta Sailaja

机构信息

Iterum Therapeutics, Old Saybrook, Connecticut, USA.

Das Statistical Consulting, Guerneville, California, USA.

出版信息

Clin Infect Dis. 2023 Jun 16;76(12):2213-2215. doi: 10.1093/cid/ciad149.

DOI:10.1093/cid/ciad149
PMID:36949581
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10273356/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0676/10273356/5361770f59c7/ciad149f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0676/10273356/5361770f59c7/ciad149f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0676/10273356/5361770f59c7/ciad149f1.jpg

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本文引用的文献

1
Opening a DOOR for Pivotal Studies: An Example for Complicated Urinary Tract Infections.为关键研究打开一扇门:复杂尿路感染的一个例子
Clin Infect Dis. 2023 Feb 8;76(3):e1166-e1167. doi: 10.1093/cid/ciac778.
2
Sulopenem for the Treatment of Complicated Urinary Tract Infections Including Pyelonephritis: A Phase 3, Randomized Trial.硫酸头孢噻肟治疗包括肾盂肾炎在内的复杂性尿路感染的 3 期随机试验。
Clin Infect Dis. 2023 Jan 6;76(1):78-88. doi: 10.1093/cid/ciac704.
3
Improving Traditional Registrational Trial End Points: Development and Application of a Desirability of Outcome Ranking End Point for Complicated Urinary Tract Infection Clinical Trials.
改进传统注册临床试验终点:复杂尿路感染临床试验结局排序终点的制定与应用。
Clin Infect Dis. 2023 Feb 8;76(3):e1157-e1165. doi: 10.1093/cid/ciac692.
4
Clinical Practice Guideline for the Management of Asymptomatic Bacteriuria: 2019 Update by the Infectious Diseases Society of America.美国传染病学会 2019 年无症状菌尿管理临床实践指南更新版。
Clin Infect Dis. 2019 May 2;68(10):1611-1615. doi: 10.1093/cid/ciz021.
5
Distribution-free confidence intervals for a parameter of Wilcoxon-Mann-Whitney type for ordered categories and progressive censoring.有序类别和渐进删失情形下Wilcoxon-Mann-Whitney型参数的无分布置信区间
Biometrics. 1989 Jun;45(2):509-21.