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

Hospital-Acquired Pneumonia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774094
• Other study ID #: C3591026
• Status: Completed
• Phase: Phase 4
• Start date: May 21, 2021
• Est. completion date: May 4, 2023

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Hospital-Acquired Pneumonia

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Baotou Central Hospital	Baotou	Inner Mongolia Autonomous Region
China	Baotou Central Hospital	Baotou	Inner Mongolia Autonomous Region
China	Peking University Third Hospital	Beijing	Beijing
China	Seventh Medical Center, The General Hospital of People's Liberation Army	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Chengdu Xinhua Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	Dongyang People's Hospital	Dongyang	Zhejiang
China	Fuyang People's Hospital	Fuyang	Anhui
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Huai'an First People's Hospital	Huai'an	Jiangsu
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	Jiangyin People's Hospital	Jiangyin	Jiangsu
China	The First Hospital of Kunming	Kunming	Yunnan
China	The First People's Hospital of Lianyungang City	Lianyungang	Jiangsu
China	Luoyang Central Hospital	Luoyang	Henan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The First People's Hospital of Nanning	Nanning	Guangxi Zhuang Autonomous Region
China	NanYang central hospital	Nanyang	Henan
China	NanYang First people's hospital	Nanyang	Henan
China	Qingyuan People's Hospital	Qingyuan	Guangdong
China	Sanya People's Hospital	Sanya	Hainan
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai Fifth People's Hospital, Fudan University	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The Second People's Hospital of Shenzhen	Shenzhen	Guangdong
China	Shiyan Renmin Hospital	Shiyan	Hubei
China	Taizhou People's Hospital	Taizhou	Jiangsu
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The 2nd Affiliated Hospital of WMU	Wenzhou	Zhejiang
China	Wenzhou Central Hospital	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Xiamen University	Xiamen
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Yueyang People's Hospital	Yueyang	Hunan
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Central People's Hospital of Zhanjiang	Zhanjiang	Guangdong
China	Henan provincial people's hospital	Zhengzhou	Henan
China	The Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of HAP participants having clinical cure		Test of Cure(TOC, Day 21 - 25)
Primary	The percentage of HAP participants having clinical cure		Test of Cure(TOC, Day 21 - 25)
Secondary	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)
Secondary	The number of HAP participants having microbiological favorable response (per-patient and per-pathogen)		Test of Cure(TOC, Day 21-Day 25)
Secondary	The number of HAP participants with death		Day 28 after enrollment
Secondary	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)
Secondary	The percentage of HAP participants having microbiological favorable response (per-patient and per-pathogen)		Test of Cure(TOC, Day 21-Day 25)
Secondary	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)
Secondary	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)
Secondary	The percentage of HAP participants with death		Day 28 after enrollment

External Links

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