PROFILE (2819-MA-1003) - version 2
Research type
Research Study
Full title
Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium Difficile Infection (CDI)
IRAS ID
181034
Contact name
Nico Hanssen
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd.
Eudract number
2014-003002-32
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Clostridium Difficile Infection (CDI) is caused by an overgrowth of bacteria called C. difficile in the colon which can cause severe diarrhoea. The condition is mostly seen in hospitalized patients that have received previous antibiotic treatments.
'The safety of fidaxomicin has yet to be investigated in patients with IBD, in whom CDI is an important consideration.
The main purpose of the study is to determine blood levels of fidaxomicin and its main metabolite (an active chemical which remains after fidaxomicin has been broken down by the body) in subjects with Inflammatory Bowel Disease (IBD) with CDI and if it is safe and effective to use in this population.
Participation in the study will last approximately 6 months. There will be 8 visit. All subjects enrolled will receive the same treatment - fidaxomicin 200 mg tablets, taken twice daily, for 10 days. During the treatment period, subjects will be asked to complete a diary and enter information daily about every bowel movement, other symptoms they might experience and the times at which the study drug was taken each day.
On Day 1 (Visit 1), Day 5 (Visit 2) and Day 10 (Visit 3) subjects will be asked to provide blood samples to measure the concentration of fidaxomicin and its main metabolite. These are called pharmacokinetic (PK) samples. On these days blood samples will be taken just prior to taking the morning dose of study drug and then at 30 minutes and 1, 1.5, 2, 3, 4, 5 and 12 hours after dosing. Subjects will then be followed up on Day 26, 40, 90 and 180 to check that they no longer have CDI and to monitor their overall health.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0229
Date of REC Opinion
1 Jul 2015
REC opinion
Further Information Favourable Opinion