cUTI, Complicated Urinary Tract Infection, cIAI, Complicated intra-abdominal infection MedDRA version: 14.1 Level: LLT Classification code 10046574 Term: Urinary tract infection NOS System Organ Class: 100000004862 MedDRA version: 14.1 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: - Patients must be =18 and =90 years of age - 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 7 days after - Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection 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 256 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
Exclusion criteria: - Patient has an APACHE II score >30 (cIAI patients only) - Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.) - Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant - Patient is immunocompromised - Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlike to survive the 4- to 5- week study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the per-patient clinical response to ceftazidime-avibactam and best available therapy at TOC in the treatment of selected serious infections caused by ceftazidime-resistant Gram negative pathogens. ;Secondary Objective: •To further evaluate the clinical response to CAZ-AVI and BAT at different visits and in patient subgroups (including entry diagnosis, pathogen, resistance mechanism, and previously failed treatment class) •To estimate the microbiological response to CAZ-AVI and BAT in the treatment of selected serious infections caused by ceftazidime-resistant Gram-negative pathogens •To evaluate the reasons for treatment change and/or discontinuation for CAZ-AVI and BAT •To estimate the 28-day, all-cause mortality among patients treated with CAZ-AVI and BAT •To evaluate the safety and tolerability profile of CAZ-AVI and BAT for the treatment of selected serious infections caused by ceftazidime-resistant Gram-negative pathogens •To evaluate the pharmacokinetics (PK) of the individual components of CAZ-AVI in this population with selected serious infections, and to characterize the relationship between the PK and clinical and microbiological response for CAZ-AVI ;Primary end point(s): The proportion of patients with clinical cure at the Test of Cure visit in the microbiological intent-to-treat (mMITT) analysis set.;Timepoint(s) of evaluation of this end point: 7-10 days after last infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)The proportion of patients with clinical cure in the microbiological modified intent to treat analysis set. 2)The proportion of patients with clinical cure in the extended microbiologically evaluable analysis set. 3)The proportion of patients with clinical cure by pathogen (eg, E. coli, Klebsiella spp., Pseudomonas aeruginosa) in the microbiological modified intent to treat analysis set. 4)The proportion of patients with clinical cure by resistance mechanism (eg, Klebsiella pneumoniae carbapenemase producer, Extended spectrum ß lactamase producer) in the microbiological modified intent to treat analysis set. 5)The proportion of patients with clinical cure by entry diagnosis (complicated intra-abdominal infection/complicated urinary tract infection) in the microbiological modified intent to treat analysis set. 6)The proportion of patients with clinical cure by pathogen (eg, E. coli, Klebsiella spp., Pseudomonas aeruginosa) in the extended microbiologically evaluable analysis set. 7)The proportion of patients with clinical sure by resistance mechanism (eg, Klebsiella pneumoniae carbapenemase producer, Extended spectrum ß lactamase producer) in the extended microbiologically evaluable analysis set. 8)The proportion of patients with clinical cure by entry diagnosis (complicated intra-abdominal infection/complicated urinary tract infection) in the extended microbiologically evaluable analysis set. 9)The proportion of patients with clinical cure by previously failed treatment class (eg, quinolone, ß lactam/ß lactamase inhibitor, third- or fourth generation cephalosporin, carbapenem), in the microbiological modified intent to treat analysis set. 10)The proportion of patients with clinical cure by previously failed treatment class (eg, quinolone, ß lactam/ß lactamase inhibitor, third- or fourth generation cephalosporin, carbapenem) in the extended microbiologically evaluable analysis set. 11)The proportion of patients with favorabl | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed