Health Condition 1: null- Nosocomial Pneumonia (NP) Ventilator Associated Pneumonia (VAP) Health Condition 2: J189- Pneumonia, unspecified organism
Conditions
Interventions
Intervention1: Ceftazidime-Avibactam: Ceftazidime plus avibactam for 7-14 days treatment
Intravenous infusion
Control Intervention1: Meropenem: Meropenem for 7-14 days treatment
Intravenous infusion
Sponsors
AstraZeneca AB
AstraZeneca Pharma India Ltd
Eligibility
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 last dose of IV study therapy. • Onset of symptoms more than or equal to 48 hours after admission or less than 7 days after discharge from an inpatient acute or chronic care facility. • New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization. • At least 1 of the following systemic signs: Fever (temperature more than 38 degree C) or hypothermia (rectal/core temperature less than 35 degree C); White blood cell count more than10,000 cells/mm3, or White blood cell count less than 4500 cells/mm3, or more than15% band forms.
Exclusion criteria
Exclusion criteria: • Pulmonary disease that precludes evaluation of therapeutic response (including, but not limited to, lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism). • Patients with lung abscess, pleural empyema or post obstructive pneumonia. • Patients with an estimated creatinine clearance 16ml/min by Cockcroft Gault formula 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 |
|---|---|
| The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses)Timepoint: Up to 25 days from randomization 21st - 25th day from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with clinical cure in the microbiologically modified intent-to-treat, microbiologically evaluable and extended Microbiologically evaluable analysis setsTimepoint: Up to 25 days from randomization 21st - 25th day from randomization ;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 setsTimepoint: at Day 21 to 25 from randomization and Day 28 from randomization;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 setsTimepoint: up to 14 days from randomization and 21 to 25 from randomization;Safety and tolerability by incidence and severity of adverse events and serious adverse events, mortality, reasons for discontinuations of study therapy, vital signs, physical exams, electrocardiogram parameters, and clinical laboratory testsTimepoint: up to 28 days from randomization;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 setsTimepoint: up to 14 days from randomization and 21 to 25 from randomization;The proportion of favorable per-pathogen microbiologic responses in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis setsTimepoint: up to 14 days from randomization and 21 to 25 from randomization;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 setsTimepoint: u | — |
Countries
Argentina, Brazil, Bulgaria, Chile, China, Czech Republic, France, Hungary, India, Italy, Japan, Mexico, Peru, Poland, Republic of Korea, Russian Federation, South Africa, Spain, Turkey, Ukraine, United Kingdom, Viet Nam
Contacts
Public ContactMs Ranju Sharma
AstraZeneca Pharma India Ltd.
Outcome results
None listed