Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Retrospective Chart Review
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

CEFTOLOZANE SULFATE

Medical condition to be studied

Renal impairment
Hepatic function abnormal
Immunosuppression
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised

Estimated number of subjects

422
Study design details

Main study objective

The objective of this study is to further characterize the safety profile of ceftobiprole in patients with impaired renal or hepatic function or immuno-suppression.

Outcomes

Primary aim: Proportion and relative frequency of Treatment-Emergent AEs in patients treated with ceftobiprole who have at least one of the following conditions: impaired renal (severe) or hepatic function or immunocompromission. The secondary aim is the assessment of ceftobiprole in the naturalistic clinical settings with respect to treatment duration and dosage as well as safety as a result of off-label use (i.e. outside labelled indications).

Data analysis plan

Aim at detection of 2–3-fold increase in frequency of AESIs in patients with risk factors compared to patients without risk factors. Sample size was calculated using a one-sided Z-test at an alpha level of 0.05 and a power of >80% Drop-out rate due to non-evaluability was estimated at 15% Per protocol a total of 422 patient charts had to be reviewed to obtain 360 evaluable charts: 180 charts from patients treated with ceftobiprole without risk factors (control group) 50 charts from patients with severe renal impairment/ ESRD 50 charts from patients with hepatic impairment 50 charts from immunocompromised patients Proportion of AESIs observed in patients with risk factors is compared to the proportion of AESIs in patients without risk factors from RETRACE (control group) and from pooled phase 3 studies (external control) Related Risk Ratio calculation and comparison