A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

INTERVENTION: investigational material(s) Generic name etc : ceftazidime‐avibactam INN of investigational material : Therapeutic category code : 619 Other antibiotic preparations (including mixed antibiotic preparations) Dosage and Administration for Investigational material : 2000mg ceftazidime plus 500mg avibactam, Intra‐Venous Treatment control material(s) Generic name etc : meropenem INN of investigational material : Therapeutic category code : 613 Antibiotic preparations acting mainly on gram‐positive, gram‐negative bacteria Dosage and Administration for Investigational material : 1000mg of Meropenem, Intra‐Venous Treatment CONDITION: Nosocomial Pneumonia (NP), Ventilator‐associated Pneumonia (VAP) INCLUSION CRITERIA: ‐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 or more after admission or <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 >38 C) or hypothermia (rectal/core temperature <35 C); White blood cell count >10,000 cells/mm3, or White blood cell count <4500 cells/mm3, or >15% band forms.