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Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

Primary Purpose

Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zavicefta, Ceftazidime-Avibactam
Best Available Treatment
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical
  • The First Affiliated Hospital of Bengbu Medical College
  • Chizhou People's Hospital
  • Fuyang People's Hospital
  • Peking University Third Hospital
  • Zhongshan Hospital Xiamen University
  • Guangzhou First People's Hospital
  • Qingyuan People's Hospital
  • Shenzhen People's Hospital
  • The Second People's Hospital of Shenzhen
  • Affiliated Hospital of Guangdong Medical University
  • Affiliated Hospital of Guilin Medical College
  • Affiliated Hospital of Zunyi Medical University
  • Affiliated Hospital of Hebei University
  • Luoyang Central Hospital
  • NanYang central hospital
  • Henan provincial people's hospital
  • Henan provincial people's hospital
  • Baotou Central Hospital
  • Jiangyin People's Hospital
  • Affiliated Hospital of Xuzhou Medical University
  • Subei People's Hospital of Jiangsu province
  • Jiangxi Provincial People's Hospital
  • Huashan Hospital, Fudan University
  • Chengdu Xinhua Hospital
  • Tianjin Chest Hospital
  • The First People's Hospital of Kunming (South Hospital)
  • The First people's Hospital of Kunming
  • The First People's Hospital of Kunming Ganmei Hospital (North Hospital)
  • Zhejiang Hospital
  • Zhejiang Provincial People's Hospital
  • Lishui People's Hospital
  • Taizhou Hospital of Zhejiang Province
  • The 2nd Affiliated Hospital of WMU
  • Wenzhou Central Hospital
  • Jiangyin People's Hospital
  • Shanghai Fifth People's Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAZ-AVI

Best Available Treatment

Arm Description

ceftazidime 2g plus avibactam 0.5g

Based on investigative site practice and local epidemiology and guideline

Outcomes

Primary Outcome Measures

The percentage of participants in Microbiologically Modified Intent to Treat (mMITT) analysis set having clinical cure

Secondary Outcome Measures

The percentage of participants in mMITT analysis set having clinical cure
The percentage of participants in Microbiologically Evaluable (ME) analysis set having clinical cure
The percentage of participants in ME analysis set having clinical cure
The percentage of participants in mMITT analysis set having favorable microbiological response
The percentage of participants in mMITT analysis set having favorable microbiological response
The percentage of participants in ME analysis set having favorable microbiological response
The percentage of participants in ME analysis set having favorable microbiological response
The percentage of participants who have died due to any cause
The number of treatment-emergent adverse events
The percentage of participants experiencing the AEs

Full Information

First Posted
April 27, 2021
Last Updated
August 29, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04882085
Brief Title
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
September 12, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia, Bacteremia, Intra-abdominal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAZ-AVI
Arm Type
Experimental
Arm Description
ceftazidime 2g plus avibactam 0.5g
Arm Title
Best Available Treatment
Arm Type
Active Comparator
Arm Description
Based on investigative site practice and local epidemiology and guideline
Intervention Type
Drug
Intervention Name(s)
Zavicefta, Ceftazidime-Avibactam
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Best Available Treatment
Intervention Description
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem
Primary Outcome Measure Information:
Title
The percentage of participants in Microbiologically Modified Intent to Treat (mMITT) analysis set having clinical cure
Time Frame
Test of Cure (TOC, Day 21 - 25)
Secondary Outcome Measure Information:
Title
The percentage of participants in mMITT analysis set having clinical cure
Time Frame
End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The percentage of participants in Microbiologically Evaluable (ME) analysis set having clinical cure
Time Frame
End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The percentage of participants in ME analysis set having clinical cure
Time Frame
Test of Cure (TOC, Day 21-Day 25)
Title
The percentage of participants in mMITT analysis set having favorable microbiological response
Time Frame
Test of Cure(TOC, Day 21-Day 25)
Title
The percentage of participants in mMITT analysis set having favorable microbiological response
Time Frame
End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The percentage of participants in ME analysis set having favorable microbiological response
Time Frame
End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Title
The percentage of participants in ME analysis set having favorable microbiological response
Time Frame
Test of Cure(TOC, Day 21-Day 25)
Title
The percentage of participants who have died due to any cause
Time Frame
Day 28
Title
The number of treatment-emergent adverse events
Time Frame
up to 32 days after the last dose of study intervention
Title
The percentage of participants experiencing the AEs
Time Frame
up to 32 days after the last dose of study intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233000
Country
China
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Chizhou People's Hospital
City
Chizhou
State/Province
Anhui
ZIP/Postal Code
247000
Country
China
Facility Name
Fuyang People's Hospital
City
Fuyang
State/Province
Anhui
ZIP/Postal Code
236000
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Qingyuan People's Hospital
City
Qingyuan
State/Province
Guangdong
ZIP/Postal Code
511518
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524000
Country
China
Facility Name
Affiliated Hospital of Guilin Medical College
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471009
Country
China
Facility Name
NanYang central hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
Henan provincial people's hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Henan provincial people's hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014000
Country
China
Facility Name
Jiangyin People's Hospital
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Chengdu Xinhua Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610055
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Facility Name
The First People's Hospital of Kunming (South Hospital)
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Facility Name
The First people's Hospital of Kunming
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Facility Name
The First People's Hospital of Kunming Ganmei Hospital (North Hospital)
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650224
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
The 2nd Affiliated Hospital of WMU
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325035
Country
China
Facility Name
Wenzhou Central Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325099
Country
China
Facility Name
Jiangyin People's Hospital
City
Jiangyin
ZIP/Postal Code
214400
Country
China
Facility Name
Shanghai Fifth People's Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200240
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3591033
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

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