Real-World Study of Ceftazidime Avibactam in China
- Conditions
- Hospital Acquired PneumoniaVentilator Acquired PneumoniaComplicated Intra Abdominal Infections
- Interventions
- Registration Number
- NCT05487586
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ceftazidime avibactam group ceftazidime avibactam group Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature.
- Primary Outcome Measures
Name Time Method Percentage of patients by source of infection Day 1 Percentage of patients by demographic characteristics Day 1 Microbiologic success rate after ceftazidime-avibactam treatment initiation Up to 1 year Percentage of patients by indication type Day 1 Percentage of isolated strains Day 1 The percentage of carbapenem-resistant organisms Day 1 Clinical success rate after ceftazidime-avibactam treatment initiation Up to 1 year Susceptibility of ceftazidime-avibactam Day 1 Percentage of Genotype Day 1
- Secondary Outcome Measures
Name Time Method The percentage of patients in each combination therapy with ceftazidime-avibactam. Up to 1 year Length of Stay (LOS) Up to 1 year The percentage of patients treated in different dose and frequency of ceftazidime-avibactam 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 receiving combination therapy with ceftazidime-avibactam. Up to 1 year Duration in days of exposure to ceftazidime-avibactam Up to 1 year Length of Stay in ICU (LOS-ICU) 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 percentage of patients by different admission diagnosis Up to 1 year The number and percentage of patients by different discharge diagnosis Up to 1 year The percentage of patients treated by ceftazidime-avibactam that died during hospitalization. Up to 1 year
Trial Locations
- Locations (17)
The Second People's Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
The First affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, China
The Affiliated People's Hospital of Ningbo University
🇨🇳Ningbo, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Tianjin Medical University General Hospital
🇨🇳Tianjing, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China