Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
NCT ID: NCT04882085
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2021-08-26
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CAZ-AVI
ceftazidime 2g plus avibactam 0.5g
Zavicefta, Ceftazidime-Avibactam
CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min.
Best Available Treatment
Based on investigative site practice and local epidemiology and guideline
Best Available Treatment
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem
Interventions
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Zavicefta, Ceftazidime-Avibactam
CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min.
Best Available Treatment
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem
Eligibility Criteria
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Inclusion Criteria
* Participant must have a diagnosis of an infection (HAP/VAP, cUTI, cIAI, BSI) due to confirmed carbapenem-resistant aerobic Gram-negative pathogens, requiring administration of IV antibacterial therapy
* Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy.
* Capable of giving signed informed consent
Exclusion Criteria
* Participant is expected to require more than 21 days of treatment
* Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
* 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).
* Participant is pregnant or breastfeeding.
* Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The First Affiliated Hospital of Bengbu Medical
Bengbu, Anhui, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Chizhou People's Hospital
Chizhou, Anhui, China
Fuyang People's Hospital
Fuyang, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
NanYang central hospital
Nanyang, Henan, China
Henan provincial people's hospital
Zhengzhou, Henan, China
Henan provincial people's hospital
Zhengzhou, Henan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Kunming (South Hospital)
Kunming, Yunnan, China
The First people's Hospital of Kunming
Kunming, Yunnan, China
The First People's Hospital of Kunming Ganmei Hospital (North Hospital)
Kunming, Yunnan, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Lishui People's Hospital
Lishui, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The 2nd Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Jiangyin People's Hospital
Jiangyin, , China
Shanghai Fifth People's Hospital, Fudan University
Shanghai, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3591033
Identifier Type: -
Identifier Source: org_study_id
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