A drug utilisation study (DUS) of the use of oral fidaxomicin in the routine clinical setting (2819-CL- 2002) (Anemone)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20087
• EU PAS number:
  EUPAS9507
• Study ID:
  20087
• Official title and acronym:
  A drug utilisation study (DUS) of the use of oral fidaxomicin in the routine clinical setting (2819-CL- 2002) (Anemone)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Spain

  United Kingdom
• Study description:
  Patients with inflammatory bowel disease, fulminant or life threatening Clostridium difficile infection were excluded from the fidaxomicin clinical programs. Data on patients with renal or hepatic impairment and pregnant patients are limited. In order to fill this gap, the sponsor has proposed a retrospective, observational, multicentre drug utilisation study conducted in Europe based on secondary use of data derived from medical records.The objective of this drug utilisation study is to further assess the use of fidaxomicin in standard clinical practice and to collect information on patient use in reallife conditions, notably estimating the proportion of patients with a medical condition of specific interest among patients treated with fidaxomicin.Adult patients with a fidaxomicin prescription between the launch of the product and the date when the first site was contacted in a country are eligible for the study. Patients enrolled in a clinical trial involving fidaxomicin will not be considered for participation in the study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World & Late Phase Research (RWLPR), Quintiles

France

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Multiple centres: 22 centres are involved in the study

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Actual: 27/02/2015

Study start date

Actual: 23/10/2015

Data analysis start date

Actual: 19/10/2016

Date of final study report

Actual: 22/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe BV

Regulatory

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

Other study registration identification numbers and links

Protocol ID number: 2819-CL-2002