Complicated Intra-Abdominal Infection (cIAI) MedDRA version: 14.0 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
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 analysis set. 2. To assess the proportion of patients with clinical cure in the microbiological modified intent-to-treat and 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 and microbiologically evaluable analysis sets. 5. To assess the proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat and 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 and microbiologically evaluable analysis sets. 7. To assess the favorable per-patient clinical response and favorable per patient microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and 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 and microbiologically evaluable anlaysis sets. 9. To assess the time to first defervescence in the clinically evaluable and microbiologically evaluable anlaysis sets for patients who have fever at study entry. 10. To assess the safety and tolerability by incidence and severity of adverse events and serious adverse events, vital signs, clinical laboratory tests, ECGs and physical exams.;Timepoint(s) of evaluation of this end point: 1. at the test of cure visit 2. at the end of treatment and late follow-up visits 3. at the end of treatment, test of cure and la | — |
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