A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ104) Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra Abdominal Infections (cIAI) in Hospitalized Adults

AstraZeneca AB0 个研究点目标入组 1,106 人开始时间: 2011年12月5日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•1. 18 to 90 years of age inclusive.
•2. 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 1 week after.
•3. Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis.
•4. Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdom infections.
•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 885
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 221

•1. Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious.
•2. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation.
•3. Patient has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for > 12 hours.
•4. Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis.
•5. Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness.

发起方