Xerava(eravacycline)治疗复杂腹腔内感染:即将开展中国III期临床试验

2020-08-29 Allan MedSci原创

该公司完成了其Xerava(eravacycline)的III期临床试验的患者入组,用以治疗复杂腹腔内感染(cIAI)的中国患者。

腹腔内感染通常由胃肠道的炎症或破裂引起。有时,腹腔感染也可来自泌尿道或女性生殖道。腹腔感染通常由多种微生物引起,可致腹腔脓肿或继发性腹膜炎,后者可能为广泛性,也可能为局限性(蜂窝织炎)。

生物制药公司Everest Medicines近日宣布,该公司完成了其Xerava(eravacycline)的III期临床试验的患者入组,用以治疗复杂腹腔内感染(cIAI)的中国患者。

Xerava(eravacycline)是一种新型、完全合成的广谱肠胃外四环素。在之前的两项全球关键研究中,Xerava在cIAI患者中具有良好的耐受性,并且与两种广泛使用的药物(ertapenem和meropenem)相比,在统计学上并不逊色。这两项研究导致Xerava在美国、欧盟和新加坡获得批准。这项中国试验的顶线结果预计将于2020年第四季度发布,并将支持Everest Medicines在中国提交新药申请。

Everest Medicines传染病首席医学官Sunny Zhu说:“我们的第一个中国III期临床试验是Everest Medicines的重要里程碑。Xerava代表着一种重要的新治疗方案,可用于处理复杂感染”。

 

原始出处:

https://www.firstwordpharma.com/node/1752954?tsid=4

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    2021-01-01 juliusluan78
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  5. 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  6. 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  7. 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  8. 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  9. 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2017年1月,外科感染学会(SIS)发布了腹腔内感染的管理指南2017修订版,SIS腹腔内感染管理指南分别于1992,2002和2010年发布,基于前几版指南,SIS专家组对该指南进行修订。该修订版指南主要包括:风险评估,感染源控制,微生物学评价,静脉应用抗菌药物,口服抗菌药物,经验性抗菌药物的应用,抗菌药物应用时机,持续时间等。

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2017 SIS指南:腹腔内感染的管理(修订版)

2017年1月,外科感染学会(SIS)发布了腹腔内感染的管理指南2017修订版,SIS腹腔内感染管理指南分别于1992,2002和2010年发布,基于前几版指南,SIS专家组对该指南进行修订。该修订版指南主要包括:风险评估,感染源控制,微生物学评价,静脉应用抗菌药物,口服抗菌药物,经验性抗菌药物的应用,抗菌药物应用时机,持续时间等。

决默沙东Zerbaxa,阿特维斯新型 产品Avycaz喜获FDA批准

全球仿制药巨头阿特维斯(Actavis)近日宣布,新型抗生素产品Avycaz获得FDA批准,用于复杂性腹腔内感染 (cIAI)(联合甲硝唑)及复杂性尿路感染 (cUTI) 的治疗。此前,FDA已授予Avycaz合格传染病产品 (QIDP)资格,并根据II期临床数据进行了优先审查,因此Avycaz应保守用于有限或无替代治疗方案的患者群体。该药的III期临床正在进行中,相关数据将用于支持Avyca