ANEMONE 2819-CL-2002
Research type
Research Study
Full title
A drug utilisation study (DUS) of the use of oral fidaxomicin in the routine clinical setting (2819-CL-2002) (“Anemone”)
IRAS ID
185796
Contact name
Surabhi Taori
Contact email
Sponsor organisation
Astellas, Pharma Europe BV
Research summary
Fidaxomicin is an antibiotic licenced to treat Clostridium difficile infection (CDI). In the initial clinical trials of this drug, patients with Inflammatory Bowel Disease, severe and life threatening CDI were excluded.In addition, there is limited data available on the clinical response and safety of this drug on patients with renal or hepatic impairment and in pregnancy. However, it is likely that post licencing, this drug may have been used in the above patient groups. Hence, the Sponsor has proposed a retrospective, observational, multicentre drug utilisation study 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 real life conditions; notably estimating the proportion of patients with the above mentioned medical condition of specific interest among patients treated with fidaxomicin. Events of death, laboratory and ECG findings along with the reason, dose, duration and outcome of treatment with Fidaxomicin will be recorded. Adult patients with a fidaxomicin prescription between the launch of the product and the date when the first site was contacted for this study in a country will be included excepting those enrolled in a clinical trial involving fidaxomicin.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0568
Date of REC Opinion
15 Sep 2015
REC opinion
Favourable Opinion