Overview

Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Pfizer
Collaborator:
Forest Laboratories
Treatments:
Avibactam
Avibactam, ceftazidime drug combination
Ceftazidime
Meropenem
Metronidazole
Thienamycins
Criteria
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:

1. Surgical sterilization

2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more
following cessation of all exogenous hormonal treatments

3. 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

4. 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