Real-World Study of Ceftazidime Avibactam in China (REACT)

Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice

This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.

Study Overview

• Status: Recruiting
• Conditions: Hospital Acquired Pneumonia; Complicated Intra Abdominal Infections; Ventilator Acquired Pneumonia
• Intervention / Treatment: Drug: ceftazidime avibactam group

Detailed Description

The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tsinghua Changgung Hospital
  • Changsha, China
    • Recruiting
    • Xiangya Hospital Central South University
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital, Sun Yat-sen University
  • Hangzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Hangzhou, China
    • Recruiting
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Hefei, China
    • Recruiting
    • The First Affiliated Hospital of Anhui Medical University
  • Nanchang, China
    • Recruiting
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China
    • Recruiting
    • Zhongda Hospital Southeast University
  • Ningbo, China
    • Recruiting
    • The Affiliated People's Hospital of Ningbo University
  • Shanghai, China
    • Recruiting
    • Shanghai Tenth People's Hospital
  • Shijiazhuang, China
    • Recruiting
    • The Third Hospital of Hebei Medical University
  • Shijiazhuang, China
    • Recruiting
    • The Second People's Hospital of Hebei Medical University
  • Suzhou, China
    • Recruiting
    • The First Affiliated Hospital Of Soochow University
  • Tianjing, China
    • Recruiting
    • Tianjin Medical University General Hospital
  • Xian, China
    • Recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Zhengzhou, China
    • Recruiting
    • Henan Provincial People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients treated with CAZ AVI for ≥1 dose in approximately 20 study sites.

Description

Inclusion criteria：

• Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
• Aged ≥ 18 years old at the time of the informed consent signature.
• Provide signed informed consent. Exclusion criteria：
• Are enrolled in any clinical trial, including enrollment in non interventional studies.
• Pregnant women.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ceftazidime avibactam group; Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature.	Drug: ceftazidime avibactam group; Non-Interventional Study; Other Names: CAZ/AVI group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical success rate after ceftazidime-avibactam treatment initiation	Up to 1 year
Microbiologic success rate after ceftazidime-avibactam treatment initiation	Up to 1 year
Percentage of patients by demographic characteristics	Day 1
Percentage of patients by indication type	Day 1
Percentage of patients by source of infection	Day 1
Percentage of isolated strains	Day 1
Susceptibility of ceftazidime-avibactam	Day 1
The percentage of carbapenem-resistant organisms	Day 1
Percentage of Genotype	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentage of patients treated in different dose and frequency of ceftazidime-avibactam	Up to 1 year
The percentage of patients receiving combination therapy with ceftazidime-avibactam.	Up to 1 year
The percentage of patients in each combination therapy with ceftazidime-avibactam.	Up to 1 year
Duration in days of exposure to ceftazidime-avibactam	Up to 1 year
Length of Stay (LOS)	Up to 1 year
Length of Stay in ICU (LOS-ICU)	Up to 1 year
The percentage of patients by different admission diagnosis	Up to 1 year
The percentage of patients with invasive procedures, source of infection management, dialysis and/or surgery	Up to 1 year
Length of mechanical ventilation	Up to 1 year
The number and percentage of patients by different discharge diagnosis	Up to 1 year
The percentage of patients with any re-admission due to recurrence of infection happened in the same location within 30 and 60 days after discharge.	Up to 1 year
The percentage of patients treated by ceftazidime-avibactam that died during hospitalization.	Up to 1 year

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ventilator acquired pneumonia; hospital acquired pneumonia; complicated intra abdominal infections; ceftazidime avibactam; carbapenem-resistant Enterobacteriaceae
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Intraabdominal Infections; Pneumonia, Ventilator-Associated; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Avibactam; Ceftazidime; Avibactam, ceftazidime drug combination
• Other Study ID Numbers: C3591037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No