Clinical trial NCT05487586: Real-World Study of Ceftazidime Avibactam in China
Official title: Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hospital Acquired Pneumonia
Ventilator Acquired Pneumonia
Complicated Intra Abdominal Infections
Keywords: hospital acquired pneumonia
ventilator acquired pneumonia
complicated intra abdominal infections
ceftazidime avibactam
carbapenem-resistant Enterobacteriaceae
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients treated with CAZ AVI for ≥1 dose in approximately 20 study sites.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical success rate after ceftazidime-avibactam treatment initiation
timeFrame: Up to 1 year
measure: Microbiologic success rate after ceftazidime-avibactam treatment initiation
timeFrame: Up to 1 year
measure: Percentage of patients by demographic characteristics
timeFrame: Day 1
measure: Percentage of patients by indication type
timeFrame: Day 1
measure: Percentage of patients by source of infection
timeFrame: Day 1
measure: Percentage of isolated strains
timeFrame: Day 1
measure: Susceptibility of ceftazidime-avibactam
timeFrame: Day 1
measure: The percentage of carbapenem-resistant organisms
timeFrame: Day 1
measure: Percentage of Genotype
timeFrame: Day 1
Secondary outcomes:
measure: The percentage of patients treated in different dose and frequency of ceftazidime-avibactam
timeFrame: Up to 1 year
measure: The percentage of patients receiving combination therapy with ceftazidime-avibactam.
timeFrame: Up to 1 year
measure: The percentage of patients in each combination therapy with ceftazidime-avibactam.
timeFrame: Up to 1 year
measure: Duration in days of exposure to ceftazidime-avibactam
timeFrame: Up to 1 year
measure: Length of Stay (LOS)
timeFrame: Up to 1 year
measure: Length of Stay in ICU (LOS-ICU)
timeFrame: Up to 1 year
measure: The percentage of patients by different admission diagnosis
timeFrame: Up to 1 year
measure: The percentage of patients with invasive procedures, source of infection management, dialysis and/or surgery
timeFrame: Up to 1 year
measure: Length of mechanical ventilation
timeFrame: Up to 1 year
measure: The number and percentage of patients by different discharge diagnosis
timeFrame: Up to 1 year
measure: 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.
timeFrame: Up to 1 year
measure: The percentage of patients treated by ceftazidime-avibactam that died during hospitalization.
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hefei
country: China
facility: The First affiliated Hospital of Anhui Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shijiazhuang
country: China
facility: The Second People's Hospital of Hebei Medical University
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjing
country: China
facility: Tianjin Medical University General Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: