作者
Bart Jan Kullberg, Claudio Viscoli, Peter G Pappas, Jose Vazquez, Luis Ostrosky-Zeichner, Coleman Rotstein, Jack D Sobel, Raoul Herbrecht, Galia Rahav, Sutep Jaruratanasirikul, Ploenchan Chetchotisakd, Eric Van Wijngaerden, Jan De Waele, Christopher Lademacher, Marc Engelhardt, Laura Kovanda, Rodney Croos-Dabrera, Christine Fredericks, George R Thompson III
发表日期
2019/5/30
期刊
Clinical Infectious Diseases
卷号
68
期号
12
页码范围
1981-1989
出版商
Oxford University Press
简介
Background
Isavuconazole was compared to caspofungin followed by oral voriconazole in a Phase 3, randomized, double-blind, multinational clinical trial for the primary treatment of patients with candidemia or invasive candidiasis.
Methods
Adult patients were randomized 1:1 to isavuconazole (200 mg intravenous [IV] three-times-daily [TID] for 2 days, followed by 200 mg IV once-daily [OD]) or caspofungin (70 mg IV OD on day 1, followed by 50 mg IV OD [70 mg in patients > 80 kg]) for a maximum of 56 days. After day 10, patients could switch to oral isavuconazole (isavuconazole arm) or voriconazole (caspofungin arm). Primary efficacy endpoint was successful overall response at the end of IV therapy (EOIVT) in patients with proven infections who received ≥1 dose of study drug (modified-intent-to-treat [mITT] population). The pre-specified noninferiority margin was 15 …
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BJ Kullberg, C Viscoli, PG Pappas, J Vazquez… - Clinical Infectious Diseases, 2019
