Retrospective Chart Review to evaluate the safety profile of ceftobiprole in patients with impaired hepatic or renal function or immunosuppression (RETRACE)

Study identification

• EU PAS number:
  EUPAS30444
• Study ID:
  48406
• Official title and acronym:
  Retrospective Chart Review to evaluate the safety profile of ceftobiprole in patients with impaired hepatic or renal function or immunosuppression (RETRACE)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain
• Study description:
  Post-authorization safety study (PASS), retrospective chart review conducted to characterize the safety profile of ceftobiprole in patients with certain risk factors. Primary aim: To estimate the proportion and relative frequency of treatment-emergent adverse events (TEAEs) with a focus on adverse events of special interest (AESIs) including hepatic disorders, hyponatraemia, acute renal failure, hypersensitivity, pseudomembranous colitis, convulsions and haemolytic disorders in patients with immunosuppression or hepatic impairment or severe renal impairment compared to ceftobiprole - treated patients without these risk factors (control). Secondary aim: To assess the use of ceftobiprole in real-world settings with regards to treatment duration, dosage and safety in “off-label” use.
• Study status:
  Finalised

Research institutions and networks

Institutions

ADVANZ Pharma

Study timelines

Date when funding contract was signed

Planned: 19/03/2019

Actual: 26/06/2019

Study start date

Planned: 09/12/2019

Actual: 30/03/2020

Date of final study report

Planned: 30/01/2024

Actual: 15/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ADVANZ PHARMA Switzerland SARL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)