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

AstraZeneca0 个研究点目标入组 1,106 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•The study should be conducted in patients aged more or equal 18 and equal or less than 65 years 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
•-Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
•-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-abdominal infections

•- 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
•- Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
•- Patient has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for more than 12 hours
•- Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
•- Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness

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