Clinical trial NCT04774094: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hospital-Acquired Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population
timeFrame: TOC visit: any day from Day 21 to 25
Secondary outcomes:
measure: Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population
timeFrame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days)
measure: Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population
timeFrame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population
timeFrame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
measure: Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population
timeFrame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
measure: Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population
timeFrame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
measure: Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population
timeFrame: EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25
measure: Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population
timeFrame: TOC visit: any day from Day 21 to 25; Day 28
measure: Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population
timeFrame: TOC visit: any day from Day 21 to 25; Day 28
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
measure: Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities
timeFrame: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
measure: Number of Participants With Vital Signs Data According to Pre-defined Criteria
timeFrame: Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Other outcomes:
Locations:
city: Fuyang
country: China
facility: Fuyang People's Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: Central People's Hospital of Zhanjiang
state: Guangdong
city: Nanning
country: China
facility: The First People's Hospital of Nanning
state: Guangxi Zhuang Autonomous Region
city: Zunyi
country: China
facility: The Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Sanya
country: China
facility: Sanya People's Hospital
state: Hainan
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Henan
city: Nanyang
country: China
facility: NanYang central hospital
state: Henan
city: Nanyang
country: China
facility: NanYang First people's hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan provincial people's hospital
state: Henan
city: Shiyan
country: China
facility: Shiyan Renmin Hospital
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang People's Hospital
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia Autonomous Region
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia Autonomous Region
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang City
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu province
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Kunming
country: China
facility: The First Hospital of Kunming
state: Yunnan
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital of WMU
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
city: Beijing
country: China
facility: Seventh Medical Center, The General Hospital of People's Liberation Army
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital, Fudan University
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: