An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

AstraZeneca AB0 个研究点目标入组 400 人开始时间: 2012年9月14日最近更新: 2014年11月3日

适应症

试验速览

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•- Patient must be =18 and =90 years of age
•- Female patients can participate if they are surgically sterile or
•completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
•- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 256
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

•- Patient has an APACHE II score >30 (cIAI patients only)
•- Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp.,
•Stenotrophomonas spp.)
•- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
•- Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.

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