Complicated Intra-Abdominal Infection (cIAI) MedDRA version: 17.0 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 to 90 years of age inclusive - Female patient is authorized to participate if at least one of the following criteria are met: (a) Surgical sterilization (b) Age =50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments (c) Age =65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
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 suspected intraabdominal 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the noninferiority of ceftazidime avibactam (CAZ104) plus metronidazole compared to meropenem alone with respect to clinical cure at the test-of-cure in patients who have at least 1 identified pathogen.;Primary end point(s): To assess the proportion of patients with clinical cure in the microbiological modified intent-to-treat analysis set.;Timepoint(s) of evaluation of this end point: At the test of cure visit;Secondary Objective: To determine the efficacy of CAZ104 plus metronidazole compared to meropenem with respect to the clinical cure at the end of treatment with IV therapy (EOT) and at the late follow-up (LFU) To determine the per-patient and per-pathogen microbiologic response of CAZ104 plus metronidazole compared to meropenem at EOT, TOC, and LFU To evaluate the efficacy of CAZ104 plus metronidazole versus meropenem in pathogens resistant to ceftazidime To compare the time to first defervescence of CAZ104 plus metronidazole versus meropenem To evaluate the safety and tolerability profile of CAZ104 plus metronidazole compared to meropenem | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the proportion of patients with clinical cure in the microbiologically evaluable and extended microbiologically evaluable analysis sets. 2. To assess the proportion of patients with clinical cure in the microbiological modified intent-to-treat, microbiologically evaluable, andextended microbiologically evaluable analysis sets. 3. To assess the proportion of patients with clinical cure in the clinically evaluable anlaysis set. 4. To assess the proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets. 5. To assess the proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable anlaysis sets. 6. To assess the favorable per-pathogen microbiologic response by minimum inhibitory concentration (MIC) categories in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets. 7. To assess the favorable per-patient clinical response and favorable perpatient microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets. 8. To assess the proportion of patients with a favorable per pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable anlaysis sets. 9. To assess the time to first defervescence in the clinically evaluable, microbiologically evaluable, and extended microbiologically evaluable anlaysis sets for patients who have fever at study entry. 10. To assess the safety and tolerability b | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Croatia, Czech Republic, Hungary, India, Israel, Latvia, Mexico, Netherlands, Peru, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed