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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hospital-Acquired Pneumonia
• Intervention / Treatment: Drug: Zavicefta, Ceftazidime-Avibactam

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Seventh Medical Center, The General Hospital of People's Liberation Army
  • Shanghai, China, 200240
    • Shanghai Fifth People's Hospital, Fudan University
  • Xiamen, China
    • Zhongshan Hospital Xiamen University
  • Anhui
    • Fuyang, Anhui, China, 236000
      • Fuyang People's Hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
    • Xiamen, Fujian, China, 361004
      • Zhongshan Hospital Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China, 510630
      • The First Affiliated Hospital of Jinan University
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University
    • Huizhou, Guangdong, China, 516008
      • Huizhou Central People's Hospital
    • Qingyuan, Guangdong, China, 511500
      • Qingyuan People's Hospital
    • Shenzhen, Guangdong, China, 518020
      • ShenZhen People's Hospital
    • Shenzhen, Guangdong, China, 518035
      • The Second People's Hospital of Shenzhen
    • Zhanjiang, Guangdong, China, 524000
      • Affiliated Hospital of Guangdong Medical University
    • Zhanjiang, Guangdong, China, 524045
      • Central People's Hospital of Zhanjiang
  • Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi Zhuang Autonomous Region, China, 530022
      • The First People's Hospital of Nanning
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • The Affiliated Hospital of Zunyi Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
    • Sanya, Hainan, China, 572022
      • Sanya People's Hospital
  • Hebei
    • Baoding, Hebei, China, 071000
      • Affiliated Hospital of Hebei University
  • Henan
    • Luoyang, Henan, China, 471009
      • Luoyang Central Hospital
    • Nanyang, Henan, China, 473000
      • Nanyang Central Hospital
    • Nanyang, Henan, China, 47300
      • Nanyang First People's Hospital
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Shiyan Renmin Hospital
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430058
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410005
      • Hunan Provincial People's Hospital
    • Yueyang, Hunan, China, 414020
      • Yueyang People's Hospital
  • Inner Mongolia Autonomous Region
    • Baotou, Inner Mongolia Autonomous Region, China, 014040
      • Baotou Central Hospital
    • Baotou, Inner Mongolia Autonomous Region, China, 014000
      • Baotou Central Hospital
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Huai'an First People's Hospital
    • Jiangyin, Jiangsu, China, 214400
      • Jiangyin People's Hospital
    • Lianyungang, Jiangsu, China, 222002
      • The First People's Hospital of Lianyungang City
    • Taizhou, Jiangsu, China, 225300
      • Taizhou People's Hospital
    • Wuxi, Jiangsu, China, 214122
      • Affiliated Hospital of Jiangnan University
    • Xuzhou, Jiangsu, China, 221002
      • The Affiliated Hospital of Xuzhou Medical University
    • Yangzhou, Jiangsu, China, 225001
      • Subei People's Hospital of Jiangsu province
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Jiangxi Provincial People's Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Affiliated Zhongshan Hospital Of Dalian University
    • Shenyang, Liaoning, China, 110016
      • General Hospital of Northern Theater Command
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 610055
      • Chengdu Xinhua Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China, 300222
      • Tianjin Chest Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650034
      • The First Hospital of Kunming
  • Zhejiang
    • Dongyang, Zhejiang, China, 322199
      • Dongyang People's Hospital
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310030
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China, 310013
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
    • Wenzhou, Zhejiang, China, 325035
      • The 2nd Affiliated Hospital of WMU
    • Wenzhou, Zhejiang, China, 325099
      • Wenzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAZ-AVI	Drug: Zavicefta, Ceftazidime-Avibactam; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): May 4, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Avibactam; Ceftazidime; Avibactam, ceftazidime drug combination
• Other Study ID Numbers: C3591026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No