EXTEND (2819-MA-1002)
Research type
Research Study
Full title
A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clostridium difficile Infection in an older population
IRAS ID
160884
Contact name
Achyut Guleri
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd.
Eudract number
2013-004619-31
Research summary
Clostridium Difficile Infection (CDI) is caused by an overgrowth of bacteria called C. difficile in the colon (the lower part of the bowel) which can cause severe diarrhoea. The condition is mostly seen in hospitalized patients that have received previous antibiotic treatments which can cause a disruption of the normal gut bacteria. Common medications currently used to treat CDI are fidaxomicin and vancomycin and other antibiotic treatments.
An important problem after having an initial episode of CDI is recurrence. This is when the disease returns after medical treatment has been stopped. This has been proven to happen less frequently in patients following treatment with fidaxomicin.
The purpose of the study is to evaluate if fidaxomicin (when used over an extended period) has an even greater effect in preventing recurrence of CDI than vancomycin (standard use) in subjects aged 60 years or older.
Participation in the study will last approximately 3 months including 6 visits or contacts with the research staff. Depending on how long the patient is in hospital, some of these visits may require the patient to visit the hospital and some can be done by telephone.
Treatment and prevention of recurrence of CDI is important. CDI has a significant impact on morbidity and mortality, particularly in high-risk patients. Mortality can be as high as 30% in patients who develop an inflamed colon. CDI also places a significant burden on healthcare systems, driven primarily by the increases in length of hospital stay and recurrences that characterize this infection. As many as 25% of patients will suffer a recurrence of infection within 30 days following treatment. This issue is particularly problematic for patient groups at high risk of recurrence or those for whom the impact of recurrence would be dangerous.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1124
Date of REC Opinion
9 Oct 2014
REC opinion
Further Information Favourable Opinion