Compare Ceftazidime Avibactam + Metronidazole vs Meropenem for hospitalized adults with complicated Intra-Abdominal Infections

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 583

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 byamenorrhea 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 [ßhCG]) 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 intraabdominal
infection; supportive radiologic imaging findings of intraabdominal
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 466
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 117

Exclusion Criteria

Patient is diagnosed with traumatic bowel perforation undergoing
surgery within 12 hours; perforation of gastroduodenal ulcers
undergoing surgery within 24 hours. Other intraabdominal 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 intraabdominal
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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