Status:
COMPLETED
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Forest Laboratories
Conditions:
Complicated Intra-Abdominal Infection
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 Vers...
Eligibility Criteria
Inclusion
- 18 to 90 years of age inclusive
- Female patient is authorized to participate if at least one of the following criteria are met:
- Surgical sterilization
- Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
- 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
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT01499290
Start Date
March 1 2012
End Date
April 1 2014
Last Update
September 6 2017
Active Locations (56)
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1
Research Site
Chula Vista, California, United States
2
Research Site
San Diego, California, United States
3
Research Site
St Louis, Missouri, United States
4
Research Site
Somers Point, New Jersey, United States