Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)

Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve.

Clinical cure: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/ VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT.

Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.

For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.

Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-pathogen microbiological response are recorded.

Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.

For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs that occurred in the study. TEAEs were AEs between first dose of study treatment and up to 32 days post last dose that were absent before treatment or that worsened relative to pretreatment state.

Hematology: Hemoglobin (Hg), hematocrit, erythrocytes: less than (<)0.8*lower limit of normal (LLN) & change (chg) more than (>)20% decrease (dec); platelets: <0.65*LLN & chg >50% dec &, >1.5* upper limit of normal (ULN) & chg >100% increase (inc); leukocytes: <0.65*LLN & chg >60% dec &, >1.6*ULN & chg >100% inc; lymphocytes, <0.25*LLN & chg >75% dec; neutrophils: <0.65*LLN & chg >75% dec &, >1.6*ULN & chg >100% inc; basophils, monocytes: >4.0* ULN & chg >300% inc. Clinical chemistry: bilirubin: >2.0*ULN & chg >150% inc; aspartate aminotransferase (AT) & Alanine AT: >3.0*ULN & chg >200% inc; alkaline phosphatase <0.5*LLN & chg >80% dec & >2.0*ULN & chg >100% inc; creatinine: >2.0*ULN & >chg 100% inc; sodium: <0.85*LLN & chg >10% dec & >1.1*ULN & chg >10% inc; potassium & chloride: <0.8*LLN & chg >20% dec & >1.2*ULN & chg >20% dec; calcium: <0.7*LLN & chg >30% dec & bicarbonate: <0.7*LLN & chg >40% dec. Clinical significance was judged by investigator.

Vital signs included diastolic blood pressure (millimeters of mercury [mmHg]); pulse rate (beats per minute [bpm]) and systolic blood pressure (mmHg). Pre-defined criteria: Diastolic blood pressure: Value <50 mmHg, Diastolic blood pressure: Change more than or equal to (>=) 20 mmHg increase, Diastolic blood pressure: Change >= 20 mmHg decrease, Pulse rate: Value <40 bpm, Pulse rate: Value >120 bpm, Systolic blood pressure: Value <90 mmHg, Systolic blood pressure: Change >= 30 mmHg increase, Systolic blood pressure: Change >= 30 mmHg decrease. One participant could have more than one vital sign abnormality.