Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD) MedDRA version: 17.0 Level: LLT Classification code 10022661 Term: Intestinal infection due to clostridium difficile System Organ Class: 100000004862
Conditions
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is 60 years of age or over. • CDI is confirmed by clinical symptoms in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization. • Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). • Subject agrees not to participate in another interventional study whilst participating in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: • Subject is taking or requiring to be treated with prohibited medications • Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours • Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment • Subject is unable to swallow oral study medication. • Subject has a current diagnosis of toxic megacolon. • Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol. • Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor. • Subject has previously participated in a CDI vaccine study • Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components. • Any clinical condition which, in the opinion of the Investigator, would not allow safe completion of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55). Sustained clinical cure is defined as clinical response at Test of Cure (TOC) and no recurrence of CDI from TOC until time of assessment.;Secondary Objective: The secondary objectives of this study are: • to compare sustained clinical cure of CDI at Day 40, Day 55 and Day 90 • to compare clinical response of CDI at 2 days after end of treatment (Day 12 or Day 27) • to compare clinical response of CDI at Day 12 • to compare TTROD in hours • to compare recurrence rate of CDI at Day 40, Day 55 and Day 90 • to compare time to recurrence after end of treatment • to compare disease-free survival after Day 10 • to compare the rate of relapse at Day 90 as determined by whole genome sequencing of C.Difficile isolates from subjects who have documented recurrence after TOC • to compare incidence of mortality and severity of adverse events at Day 90 • to assess change in Health Related Quality of Life from baseline to Day 12, Day 27, Day 40, Day 55 and recurrence using the EQ-5D-5L questionnaire • to compare readmissions and length of hospital stay at Day 90;Primary end point(s): The primary endpoint of this study is sustained clinical cure of CDI;Timepoint(s) of evaluation of this end point: 30 days after end of treatment (Day 40 or Day 55) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Sustained clinical cure of CDI at Day 40, Day 55 and Day 90 • Clinical response of CDI at 2 days after EOT (Day 12 or Day 27) • Clinical response of CDI at Day 12 • TTROD in hours • Recurrence rate of CDI at Day 40, Day 55 and Day 90 • Time to recurrence after end of treatment (only for subjects with clinical response) • Disease-free survival after Day 10 (only for subjects with clinical response) • Rate of relapse at Day 90 as determined by whole genome sequencing of C.difficile isolates from Subjects who have documented recurrence after TOC;Timepoint(s) of evaluation of this end point: Day 12, 27, 40 , 55, 90 depending on treatment and endpoint | — |
Countries
Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Romania, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contacts
Public ContactAndreas Karas
Astellas Pharma Europe Ltd.
Outcome results
None listed