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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Name of medicine:
  ZAVICEFTA
• Medical condition to be studied:
  Abdominal infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  180

Study design details

• Main study objective:
  To describe the effectiveness of CAZ-AVI for the treatment of cIAI in terms of clinical response in patients who were exposed to CAZ-AVI for at least 72 hours To describe the safety of CAZ-AVI in terms of drug exposure, in-hospital all-cause mortality, incidence of AEs with explicit attribution to CAZ-AVI To describe the treatment patterns of CAZ-AVI for cIAI patients
• Outcomes:
  in-hospital all-cause mortality, in-hospital cIAI-related mortality, clinical response (categorized as clinical cure, clinical failure and clinical indeterminate). all-cause in-hospital mortality, incidence of AEs and SAEs with explicit attribution to CAZ-AVI, counts of patients with CAZ-AVI exposure in specific scenarios, renal and hepatic function parameters. cIAI infection source control procedure before CAZ-AVI treatment, prior antibiotic therapies, CAZ-AVI dosage, concomitant antibiotic therapy, other antibiotics used/prescribed after CAZ-AVI treatment
• Data analysis plan:
  All statistical analysis performed will be descriptive. Results will be presented for all patients who meet the eligible criteria. Missing data will not be imputed in this study. Number and percentage of missing data for each variable will be presented but be excluded in the calculation of mean, median and percentage.

Documents

Study results

C3591039 NI Study Report Abstract (Final approval date 15 Sep 2023; Administrative change date 26 Sep 2023)_已标记密文

Study report

C3591039 NI Study Report (Final approval date 15 Sep 2023; Administrative change date 26 Sep 2023)_已标记密文