CIDに報告された、ACTIVE Trial
Isavuconazole vs Caspofungin RCT
感想
残念。非劣勢ならず。
それにしても、本文の考察は、シンプルで短く、言い訳も少ない。
潔いのか、諦め仕事なのか。。
"The limitations of the present study include the exclusion of pediatric patients and the small proportion of patients with neutropenia. Whereas these results provide additional support for the observation that echinocandins are associated with fewer early efficacy failures, we were not able to identify specific predictors of unfavorable outcomes with isavuconazole. However, an evaluation of the exposure-response relationships from this study might be helpful in this regard."
Abstract
Isavuconazole was compared to caspofungin followed by oral voriconazole in a phase 3, randomized, double-blind, multinational clinical trial (ACTIVE; NCT00413218) for primary treatment of patients with candidemia or invasive candidiasis.
Adult patients were randomized 1:1 to isavuconazole (200 mg IV TID for 2 days, followed by 200 mg IV QD) or caspofungin (70 mg IV QD on day 1, followed by 50 mg IV QD [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). The primary efficacy endpoint was successful overall response at end of IV therapy (EOIVT) in patients with proven infection who received ≥1 dose of study drug (modified-intent-to-treat [mITT] population). The pre-specified noninferiority margin was 15%. Secondary outcomes (mITT) were successful overall response at 2 weeks after end of treatment, all-cause mortality at days 14 and 56, and safety.
Of 450 patients randomized, 400 comprised the mITT population. Baseline characteristics were balanced between groups. Successful overall response at EOIVT was observed in 60.3% of patients in the isavuconazole arm, and 71.1% in the caspofungin arm, (adjusted difference [95% confidence interval] -10.8 [-19.9, -1.8]). The secondary endpoints, all-cause mortality, and safety were similar between arms, while median time to clearance of the bloodstream was comparable in both groups.
This study did not demonstrate the non-inferiority of isavuconazole to caspofungin for primary treatment of invasive candidiasis. Secondary endpoints were similar between both groups.
