AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, ACTIVE-CONTROLLED STUDY TO ESTIMATE THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) VERSUS BEST AVAILABLE TREATMENT (BAT) IN THE TREATMENT OF INFECTIONS DUE TO CARBAPENEM-RESISTANT GRAM-NEGATIVE PATHOGENS IN CHINESE ADULTS
Who is this study for? Patients with Bacteremia, Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia
Status: Completed
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia \[HAP\] (including Ventilator-Associated Pneumonia \[VAP\]); Complicated Urinary-Tract Infection \[cUTI\]; Complicated Intra-Abdominal Infection \[cIAI\]; Bloodstream Infection \[BSI\]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female \>18 years of age
• 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
Locations
Other Locations
China
Affiliated Hospital of Hebei University
Baoding
Baotou Central Hospital
Baotou
Peking University Third Hospital
Beijing
The First Affiliated Hospital of Bengbu Medical
Bengbu
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Chengdu Xinhua Hospital
Chengdu
Chizhou People's Hospital
Chizhou
Fuyang People's Hospital
Fuyang
Guangzhou First People's Hospital
Guangzhou
Affiliated Hospital of Guilin Medical College
Guilin
Zhejiang Hospital
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Jiangyin People's Hospital
Jiangyin
Jiangyin People's Hospital
Jiangyin
The First people's Hospital of Kunming
Kunming
The First People's Hospital of Kunming (South Hospital)
Kunming
The First People's Hospital of Kunming Ganmei Hospital (North Hospital)
Kunming
Lishui People's Hospital
Lishui
Luoyang Central Hospital
Luoyang
Jiangxi Provincial People's Hospital
Nanchang
NanYang central hospital
Nanyang
Qingyuan People's Hospital
Qingyuan
Huashan Hospital, Fudan University
Shanghai
Shanghai Fifth People's Hospital, Fudan University
Shanghai
Shenzhen People's Hospital
Shenzhen
The Second People's Hospital of Shenzhen
Shenzhen
Taizhou Hospital of Zhejiang Province
Taizhou
Tianjin Chest Hospital
Tianjin
The 2nd Affiliated Hospital of WMU
Wenzhou
Wenzhou Central Hospital
Wenzhou
Zhongshan Hospital Xiamen University
Xiamen
Affiliated Hospital of Xuzhou Medical University
Xuzhou
Subei People's Hospital of Jiangsu province
Yangzhou
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Henan provincial people's hospital
Zhengzhou
Henan provincial people's hospital
Zhengzhou
Affiliated Hospital of Zunyi Medical University
Zunyi
Time Frame
Start Date:2021-08-26
Completion Date:2023-08-31
Participants
Target number of participants:60
Treatments
Experimental: CAZ-AVI
ceftazidime 2g plus avibactam 0.5g
Active_comparator: Best Available Treatment
Based on investigative site practice and local epidemiology and guideline