Real-World Study of Ceftazidime Avibactam in China

Study Overview
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Brief Summary
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This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.

Detailed Description
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The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.

Official Title
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Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice

Conditions
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Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections

Intervention / Treatment
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* Drug: ceftazidime avibactam group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria： Initiate ≥1 dose of ceftazidime-avibactam during hospitalization. Aged ≥ 18 years old at the time of the informed consent signature. Provide signed informed consent. Exclusion criteria： Are enrolled in any clinical trial, including enrollment in non interventional studies. Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ceftazidime avibactam group<br>Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature. | Drug: ceftazidime avibactam group<br>* Non-Interventional Study<br>* Other names: CAZ/AVI group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate after ceftazidime-avibactam treatment initiation |  | Up to 1 year | 
| Microbiologic success rate after ceftazidime-avibactam treatment initiation |  | Up to 1 year | 
| Percentage of patients by demographic characteristics |  | Day 1 | 
| Percentage of patients by indication type |  | Day 1 | 
| Percentage of patients by source of infection |  | Day 1 | 
| Percentage of isolated strains |  | Day 1 | 
| Susceptibility of ceftazidime-avibactam |  | Day 1 | 
| The percentage of carbapenem-resistant organisms |  | Day 1 | 
| Percentage of Genotype |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients treated in different dose and frequency of ceftazidime-avibactam |  | Up to 1 year | 
| The percentage of patients receiving combination therapy with ceftazidime-avibactam. |  | Up to 1 year | 
| The percentage of patients in each combination therapy with ceftazidime-avibactam. |  | Up to 1 year | 
| Duration in days of exposure to ceftazidime-avibactam |  | Up to 1 year | 
| Length of Stay (LOS) |  | Up to 1 year | 
| Length of Stay in ICU (LOS-ICU) |  | Up to 1 year | 
| The percentage of patients by different admission diagnosis |  | Up to 1 year | 
| The percentage of patients with invasive procedures, source of infection management, dialysis and/or surgery |  | Up to 1 year | 
| Length of mechanical ventilation |  | Up to 1 year | 
| The number and percentage of patients by different discharge diagnosis |  | Up to 1 year | 
| The percentage of patients with any re-admission due to recurrence of infection happened in the same location within 30 and 60 days after discharge. |  | Up to 1 year | 
| The percentage of patients treated by ceftazidime-avibactam that died during hospitalization. |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospital acquired pneumonia, ventilator acquired pneumonia, complicated intra abdominal infections, ceftazidime avibactam, carbapenem-resistant Enterobacteriaceae