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

Conditions: Complicated Intra-Abdominal Infection (cIAI)
MedDRA version: 14.0Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-003895-35-GR

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1106

Inclusion Criteria

1. 18 to 90 years of age inclusive.
2. Female patients can participate 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.
3. Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis.
4. 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-abdom 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 885
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 221

Exclusion Criteria

1. 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.
2. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation.
3. Patient has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for > 12 hours.
4. Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis.
5. Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness.