nosocomial pneumonia (NP), ventilator-associated pneumonia (VAP)
Conditions
Interventions
Product Name: ceftazidime avibactam
Product Code: CAZ-AVI
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: CEFTAZIDIME PENTAHYDRATE
CAS Number: 78439-06-2
Con
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 to 90 years of age inclusive Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after Onset of symptoms =48 hours after admission or 38°C) or hypothermia (rectal/core temperature 10,000 cells/mm3, or White blood cell count 15% band forms 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 961 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 553
Exclusion criteria
Exclusion criteria: Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis,cystic fibrosis, granulomatous disease, fungal pulmonary infection orrecent pulmonary embolism). Patients with lung abscess, pleural empyema or post obstructive pneumonia. Patients with an estimated creatinine clearance <16ml/min by Cockcroft Gault formula (see Appendix E) or patients expected to require haemodialysis or other renal support while on study therapy. Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure. Patients receiving hemodialysis or peritoneal dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non-inferiority of ceftazidime-avibactam compared to meropenem with respect to clinical cure at the test of cure visit in patients in the clinically modified intent-to-treat population and patients in the clinically evaluable population;Secondary Objective: To determine the efficacy of CAZ-AVI compared to meropenem with respect to the clinical cure at end of treatment in the clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable populations and at test of cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable populations To determine the efficacy of CAZ-AVI compared to meropenem with respect to the per patient microbiologic response and per-pathogen microbiologic response at the EOT and test of cure visits To evaluate the efficacy of CAZ-AVI and meropenem in patients with pathogens resistant to ceftazidime To estimate the all-cause mortality at test of cure and at Day 28 To estimate the proportion of patients discharged from hospital up to the test of cure visit To evaluate the safety and tolerability To evaluate the pharmacokinetics;Primary end point(s): The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses);Timepoint(s) of evaluation of this end point: at test of cure visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of patients with clinical cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets The proportion of patients with clinical cure in clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets The proportion of patients with a favorable per-patient microbiologic response in microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets The proportion of favorable per-pathogen microbiologic responses in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets The proportion of favorable per-pathogen microbiologic responses by minimum inhibitory concentration categories in microbiologically modified intent-to-treat, microbiologically evaluable and extended-microbiologically evaluable analysis sets The proportion of patients with clinical cure in patients with pathogens resistant to ceftazidime in clinically evaluable, clinically modified intent-to-treat, microbiologically evaluable analysis sets Proportion of patients with a favorable per-patient microbiologic response in patients with pathogens resistant to ceftazidime in microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets The proportion of favorable per-pathogen microbiologic responses in patients with pathogens resistant to ceftazidime in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable, clinically modified intent-to-treat and microbiologically modified intent-to-treat analysis sets ;Timep | — |
Countries
Argentina, Brazil, Bulgaria, Chile, China, Czech Republic, France, Greece, Hungary, India, Italy, Japan, Latvia, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Turkey, Ukraine, United Kingdom, Vietnam
Contacts
Public ContactInformation Center
Astrazeneca
Outcome results
None listed