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

Study Overview
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Brief Summary
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This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.

Official Title
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A SINGLE ARM, OPEN-LABEL, MULTI-CENTER, INTERVENTIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHINESE ADULTS WITH HAP (INCLUDING VAP)

Conditions
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Hospital-Acquired Pneumonia

Intervention / Treatment
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* Drug: Zavicefta, Ceftazidime-Avibactam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants ≥18 and ≤90 years of age. Onset of symptoms ≥48 hours 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 screening. Participants have systemic signs and respiratory signs or symptoms of HAP/VAP Exclusion Criteria: Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Participant is expected to require a treatment course for HAP longer than 14 days. The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours. Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 or <10 using the most recent available data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAZ-AVI<br> | Drug: Zavicefta, Ceftazidime-Avibactam<br>* Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of HAP participants having clinical cure |  | Test of Cure(TOC, Day 21 - 25) | 
| The percentage of HAP participants having clinical cure |  | Test of Cure(TOC, Day 21 - 25) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of HAP participants having clinical cure |  | End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose) | 
| The number of HAP participants having microbiological favorable response (per-patient and per-pathogen) |  | Test of Cure(TOC, Day 21-Day 25) | 
| The number of HAP participants with death |  | Day 28 after enrollment | 
| The percentage of HAP participants having clinical cure |  | End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose) | 
| The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen) |  | Test of Cure(TOC, Day 21-Day 25) | 
| The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen) |  | End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose) | 
| The number of HAP participants having microbiological favorable response (per-patient and per-pathogen) |  | End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose) | 
| The percentage of HAP participants with death |  | Day 28 after enrollment |