Prospective, observational cohort, evaluating the incidence of nephrotoxicity, and other adverse events of interest, in patients treated with the higher recommended teicoplanin loading dose (12 mg/kg twice a day), and comparison with external historical comparator data (OBS13842)

Study identification

• EU PAS number:
  EUPAS12423
• Study ID:
  35696
• Official title and acronym:
  Prospective, observational cohort, evaluating the incidence of nephrotoxicity, and other adverse events of interest, in patients treated with the higher recommended teicoplanin loading dose (12 mg/kg twice a day), and comparison with external historical comparator data (OBS13842)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Poland

  Romania

  United Kingdom
• Study description:
  The primary objective is to determine the incidence of nephrotoxicity reported in association with teicoplanin higher loading doses of 12 mg/kg twice a day, over the loading dose period (up to day -10). In addition, external historical comparison of nephrotoxicity incidence rates using teicoplanin lower loading dose and vancomycin literature data will be provided.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Multiple centres: 24 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:15/07/2015

Actual:15/07/2015

Study start date

Planned:31/03/2016

Actual:22/04/2016

Data analysis start date

Planned:04/09/2017

Actual:19/03/2018

Date of interim report, if expected

Planned:04/12/2017

Actual:18/06/2018

Date of final study report

Planned:20/01/2020

Actual:18/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)