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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 26, 2021
Primary Completion Date
August 31, 2023
Completion Date
August 31, 2023
Last Updated
October 21, 2024
60
ACTUAL participants
Zavicefta, Ceftazidime-Avibactam
DRUG
Best Available Treatment
DRUG
Lead Sponsor
Pfizer
NCT05488340
NCT07246837
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07308808