Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
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
1 other identifier
interventional
60
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2021
Typical duration for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedStudy Start
First participant enrolled
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedResults Posted
Study results publicly available
October 21, 2024
CompletedOctober 21, 2024
August 1, 2024
2 years
April 27, 2021
August 1, 2024
August 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection \[cIAI\], complicated urinary-tract infection \[cUTI\], hospital-acquired pneumonia/ventilator-associated pneumonia \[HAP/VAP\] or bloodstream infection \[BSI\]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method.
At TOC visit (From Day 21 up to Day 24)
Secondary Outcomes (14)
Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set
At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set
At EOT visit (up to 24 hours after the last infusion on Day 14)
Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set
At EOT visit (up to 24 hours after the last infusion on Day 14)
Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set
At TOC visit (From Day 21 up to Day 24)
Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set
At TOC visit (From Day 21 up to Day 24)
- +9 more secondary outcomes
Study Arms (2)
CAZ-AVI
EXPERIMENTALceftazidime 2g plus avibactam 0.5g
Best Available Treatment
ACTIVE COMPARATORBased on investigative site practice and local epidemiology and guideline
Interventions
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.
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (37)
The First Affiliated Hospital of Bengbu Medical
Bengbu, Anhui, 233000, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Chizhou People's Hospital
Chizhou, Anhui, 247000, China
Fuyang People's Hospital
Fuyang, Anhui, 236000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Qingyuan People's Hospital
Qingyuan, Guangdong, 511518, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541001, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Luoyang Central Hospital
Luoyang, Henan, 471009, China
NanYang central hospital
Nanyang, Henan, 473000, China
Henan provincial people's hospital
Zhengzhou, Henan, 450000, China
Henan provincial people's hospital
Zhengzhou, Henan, 450003, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014000, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Chengdu Xinhua Hospital
Chengdu, Sichuan, 610055, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
The First People's Hospital of Kunming (South Hospital)
Kunming, Yunnan, 650034, China
The First people's Hospital of Kunming
Kunming, Yunnan, 650034, China
The First People's Hospital of Kunming Ganmei Hospital (North Hospital)
Kunming, Yunnan, 650224, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Lishui People's Hospital
Lishui, Zhejiang, 323000, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
The 2nd Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325035, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325099, China
Jiangyin People's Hospital
Jiangyin, 214400, China
Shanghai Fifth People's Hospital, Fudan University
Shanghai, 200240, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 11, 2021
Study Start
August 26, 2021
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
October 21, 2024
Results First Posted
October 21, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.