A Real-World Observational Study of Zavicefta® (CAZ-AVI) to Describe the Effectiveness, Safety and Treatment Patterns Among Patients Infected with Complicated Intra-abdominal Infections (cIAI) in China

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48736
• EU PAS number:
  EUPAS48735
• Study ID:
  48736
• Official title and acronym:
  A Real-World Observational Study of Zavicefta® (CAZ-AVI) to Describe the Effectiveness, Safety and Treatment Patterns Among Patients Infected with Complicated Intra-abdominal Infections (cIAI) in China
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  It is a single-arm, multi-center, retrospective, observational study. The study will include hospitalized patients who received CAZ-AVI for the treatment of cIAI between 2019.9.6 (CAZ-AVI commercial launch date in China) and 2022.7.6. The study data will be abstracted from the electronic medical record (EMR), hospital information system (HIS) and laboratory information system (LIS) of several hospitals in China. To ensure good representativeness, hospitals graded as Tertiary A by China government (the highest grade of a three-level hospital classification system in China) from different provinces with large patient pools will be selected. All comers who meet the inclusion/exclusion criteria will be included.
• Study status:
  Planned

Research institutions and networks

Institutions

Sir Run Run Shaw Hospital

Study timelines

Date when funding contract was signed

Planned: 20/09/2022

Actual: 20/09/2022

Study start date

Planned: 30/09/2022

Data analysis start date

Planned: 31/03/2023

Date of final study report

Planned: 28/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable