A Study Comparing Ceftazidime-Avibactam+Metronidazole Versus Meropenem in Adults With Complicated Intra-abdominal Infections

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

Inclusion Criteria:

- 18 to 90 years of age inclusive

- Female patient is authorized to participate if at least one of the following criteria
are met: (a) Surgical sterilization (b) Age ≥50 years and postmenopausal as defined
by amenorrhea for 12 months or more following cessation of all exogenous hormonal
treatments (c) Age <50 years and postmenopausal as defined by documented LH and FSH
levels in the postmenopausal range PLUS amenorrhea for 12 months or more following
cessation of all exogenous hormonal treatments (d) Patient has a negative serum
pregnancy test (serum ß-human chorionic gonadotropin [ß-hCG]) within 1 day prior to
study entry, and agrees to use highly effective contraception methods during
treatment and for at least 7 days after last dose of IV study therapy -
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

Exclusion Criteria:

- 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 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, including septic shock that is
associated with a high risk of mortality