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

Phase 3

Completed

Conditions: Health Condition 1: null- Treatment of Complicated Intra-Abdominal Infections

Registration Number: CTRI/2012/07/002797

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1106

Inclusion Criteria

The study should be conducted in patients aged more or equal 18 and equal or less than 65 years if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 1 week after.

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.

In India, upper age limit is less than equal to 65.

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 evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for more than 12 hours.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Cure as Measured by proportion of patients meeting cure criteria in the microbiological modified Intent-To-Treat analysis set.Timepoint: 28 to 35 days after start of study drug.

Secondary Outcome Measures