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

Completed · Phase 3

Conditions studied: Complicated Intra-Abdominal Infection

In brief

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.

Key facts

Study ID

NCT01499290

Run by

Pfizer

People needed

493

Starts

2012-03-01

Expected to finish

2014-04-01

Last updated by the study team

2017-09-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — San Diego, California, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Somers Point, New Jersey, United States
• Research Site — Córdoba, Argentina
• Research Site — Rosario, Argentina
• Research Site — Rousse, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Zagreb, Croatia
• Research Site — Děčín, Czechia
• Research Site — Hradec Králové, Czechia
• Research Site — Jihlava, Czechia
• Research Site — Olomouc, Czechia
• Research Site — Prague, Czechia
• Research Site — Teplice, Czechia
• Research Site — Budapest, Hungary
• Research Site — Székesfehérvár, Hungary
• Research Site — Bangalore, India
• Research Site — Pune, India
• Research Site — Trivandrum, India
• Research Site — Vadodara, India
• Research Site — Hadera, Israel
• Research Site — Haifa, Israel
• Research Site — Riga, Latvia
• Research Site — Alor Star, Malaysia
• Research Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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