REACT: Real-World Study of Ceftazidime Avibactam in China

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05487586

Collaborator

(none)

400

Enrollment

5.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hospital Acquired Pneumonia Ventilator Acquired Pneumonia Complicated Intra Abdominal Infections	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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Real-World Observational Study of Zavicefta® (Ceftazidime-avibactam, CAZ-AVI) to Characterize Effectiveness

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.