RECARBRIO(亚胺培南、西司他丁和雷巴坦)或能“力克”呼吸机相关细菌性肺炎

2020-05-06 Allan MedSci原创

RESTORE-IMI 2是一项随机、对照、双盲的III期临床试验,旨在评估RECARBRIO治疗成人医院获得性或呼吸相关细菌性肺炎。

默克公司今日宣布了RESTORE-IMI 2的结果,RESTORE-IMI 2是一项随机、对照、双盲的III期临床试验,旨在评估RECARBRIO(亚胺培南、西司他丁和雷巴坦)治疗成人医院获得性或呼吸机相关细菌性肺炎(HABP/VABP)的有效性。结果表明,在研究的主要终点和次要终点上,RECARBRIO与哌拉西林和他唑巴坦(PIP/TAZ)相比,具有非劣势。2020年2月,美国FDA接受了RECARBRIO治疗该类患者的补充新药申请(sNDA)。

默克研究实验室传染病学副总裁Joan Butterton博士说:“我们很高兴地发布RESTORE-IMI 2临床试验的结果,该结果进一步证明了RECARBRIO治疗HABP/VABP的潜力”。

在该研究中,113个临床试验中心的537位患者按1:1比例随机分配,分别接受RECARBRIO或PIP/TAZ。主要终点是第28天的全因死亡率,次要终点是早期随访(完成治疗后7至14天)的临床反应。

 

原始出处:

https://www.firstwordpharma.com/node/1721738?tsid=4

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    2020-05-08 Boyinsh
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