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

Primary Purpose

Hospital-Acquired Pneumonia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zavicefta, Ceftazidime-Avibactam
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospital-Acquired Pneumonia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuyang People's Hospital
  • Peking University Third Hospital
  • The First Affiliated Hospital of Fujian Medical University
  • Zhongshan Hospital Xiamen University
  • Guangzhou First People's Hospital
  • ZhuJiang Hospital of Southern Medical University
  • The First Affiliated Hospital of Jinan University
  • Huizhou Central People's Hospital
  • Qingyuan People's Hospital
  • Shenzhen People's Hospital
  • The Second People's Hospital of Shenzhen
  • Affiliated Hospital of Guangdong Medical University
  • Central People's Hospital of Zhanjiang
  • The First People's Hospital of Nanning
  • The Affiliated Hospital of Zunyi Medical University
  • Hainan General Hospital
  • Sanya People's Hospital
  • Affiliated Hospital of Hebei University
  • Luoyang Central Hospital
  • NanYang central hospital
  • NanYang First people's hospital
  • Henan provincial people's hospital
  • Shiyan Renmin Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Renmin Hospital of Wuhan University
  • Hunan Provincial People's Hospital
  • Yueyang People's Hospital
  • Baotou Central Hospital
  • Baotou Central Hospital
  • Huai'an First People's Hospital
  • Jiangyin People's Hospital
  • The First People's Hospital of Lianyungang City
  • Taizhou People's Hospital
  • Affiliated Hospital of Jiangnan University
  • The Affiliated Hospital of Xuzhou Medical University
  • Subei People's Hospital of Jiangsu province
  • Jiangxi Provincial People's Hospital
  • Affiliated Zhongshan Hospital of Dalian University
  • General Hospital of Northern Theater Command
  • General Hospital of Ningxia Medical University
  • Huashan Hospital Fudan University
  • West China Hospital of Sichuan University
  • Chengdu Xinhua Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Chest Hospital
  • The First Hospital of Kunming
  • Dongyang People's Hospital
  • Zhejiang Hospital
  • Zhejiang Provincial People's Hospital
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • Zhejiang Hospital
  • The 2nd Affiliated Hospital of WMU
  • Wenzhou Central Hospital
  • Seventh Medical Center, The General Hospital of People's Liberation Army
  • Shanghai Fifth People's Hospital, Fudan University
  • Zhongshan Hospital Xiamen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAZ-AVI

Arm Description

Outcomes

Primary Outcome Measures

The number of HAP participants having clinical cure
The percentage of HAP participants having clinical cure

Secondary Outcome Measures

The number of HAP participants having clinical cure
The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)
The number of HAP participants with death
The percentage of HAP participants having clinical cure
The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)
The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)
The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)
The percentage of HAP participants with death

Full Information

First Posted
February 5, 2021
Last Updated
August 29, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04774094
Brief Title
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-Acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAZ-AVI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zavicefta, Ceftazidime-Avibactam
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of HAP participants having clinical cure
Time Frame
Test of Cure(TOC, Day 21 - 25)
Title
The percentage of HAP participants having clinical cure
Time Frame
Test of Cure(TOC, Day 21 - 25)
Secondary Outcome Measure Information:
Title
The number of HAP participants having clinical cure
Time Frame
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame
Test of Cure(TOC, Day 21-Day 25)
Title
The number of HAP participants with death
Time Frame
Day 28 after enrollment
Title
The percentage of HAP participants having clinical cure
Time Frame
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame
Test of Cure(TOC, Day 21-Day 25)
Title
The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)
Time Frame
End of Treatment(EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The percentage of HAP participants with death
Time Frame
Day 28 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Fuyang People's Hospital
City
Fuyang
State/Province
Anhui
ZIP/Postal Code
236000
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
ZhuJiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Huizhou Central People's Hospital
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516008
Country
China
Facility Name
Qingyuan People's Hospital
City
Qingyuan
State/Province
Guangdong
ZIP/Postal Code
511500
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524000
Country
China
Facility Name
Central People's Hospital of Zhanjiang
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524045
Country
China
Facility Name
The First People's Hospital of Nanning
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530022
Country
China
Facility Name
The Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Sanya People's Hospital
City
Sanya
State/Province
Hainan
ZIP/Postal Code
572022
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471009
Country
China
Facility Name
NanYang central hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
NanYang First people's hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
47300
Country
China
Facility Name
Henan provincial people's hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Shiyan Renmin Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430058
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Yueyang People's Hospital
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414020
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014000
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014040
Country
China
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Jiangyin People's Hospital
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Facility Name
The First People's Hospital of Lianyungang City
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214122
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330038
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Chengdu Xinhua Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610055
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Facility Name
The First Hospital of Kunming
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Facility Name
Dongyang People's Hospital
City
Dongyang
State/Province
Zhejiang
ZIP/Postal Code
322199
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310030
Country
China
Facility Name
The 2nd Affiliated Hospital of WMU
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325035
Country
China
Facility Name
Wenzhou Central Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325099
Country
China
Facility Name
Seventh Medical Center, The General Hospital of People's Liberation Army
City
Beijing
Country
China
Facility Name
Shanghai Fifth People's Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3591026
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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