A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ104) Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra Abdominal Infections (cIAI) in Hospitalized Adults
- Conditions
- Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Complicated Intra-Abdominal Infection (cIAI)MedDRA version: 14.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862
- Registration Number
- EUCTR2011-003893-97-HU
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1066
1. 18 to 90 years of age inclusive.
2. Female patient is authorized to participate in this clinical study if she has been surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy and must be willing, during treatment and for at least 7 days after last dose of IV study therapy, to practice highly effective methods of birth control.
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
1. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation.
2. 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.
3. Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis.
4. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method