Real-World Study of Ceftazidime Avibactam in China

NCT ID: NCT05487586

Last Updated: 2025-09-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-20

Study Completion Date

2024-07-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hospital Acquired Pneumonia Ventilator Acquired Pneumonia Complicated Intra Abdominal Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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ceftazidime avibactam group

Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature.

ceftazidime avibactam group

Intervention Type DRUG

Non-Interventional Study

Interventions

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ceftazidime avibactam group

Non-Interventional Study

Intervention Type DRUG

Other Intervention Names

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CAZ/AVI group

Eligibility Criteria

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Inclusion Criteria

* Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
* Aged ≥ 18 years old at the time of the informed consent signature.

Exclusion Criteria

* Are enrolled in any clinical trial, including enrollment in non interventional studies.
* Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Beijing Tsinghua Changgung Hospital

Beijing, , China

Site Status

Xiangya Hospital Central South University

Changsha, , China

Site Status

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

Site Status

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, , China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Site Status

The First affiliated Hospital of Anhui Medical University

Hefei, , China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

Zhongda Hospital Southeast University

Nanjing, , China

Site Status

The Affiliated People's Hospital of Ningbo University

Ningbo, , China

Site Status

Shanghai Tenth People's Hospital

Shanghai, , China

Site Status

The Second People's Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

The Third Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status

Tianjin Medical University General Hospital

Tianjing, , China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

Henan Provincial People's Hospital

Zhengzhou, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3591037

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

Other Identifiers

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C3591037

Identifier Type: -

Identifier Source: org_study_id

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