The main 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
364
oral tablets administered in an extended pulsed regimen
oral capsule
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
Time frame: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the ESCMID criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
Time frame: Day 40, 55, 90
Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity \[clinical, laboratory, radiological\] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the patient is not worsening on treatment) at TOC.
Time frame: Day 12, 27
Percentage of Participants with a Clinical Response of CDI at Day 12
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Site AT43002
Graz, Austria
Site AT43003
Linz, Austria
Site AT43001
Salzburg, Austria
Site BE32007
Aalst, Belgium
Site BE32006
Bruges, Belgium
Site BE32001
Brussels, Belgium
Site BE32005
Brussels, Belgium
Site BE32008
Liège, Belgium
Site HR38506
Osijek, Croatia
Site HR38503
Rijeka, Croatia
...and 99 more locations
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity \[clinical, laboratory, radiological\] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the participant is not worsening on treatment) at TOC.
Time frame: Day 12
Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
For participants with a recurrence after TOC, whole genome sequencing of isolates is performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse is defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs).
Time frame: Baseline through day 90
Time to Resolution of Diarrhea (TTROD)
Time to resolution of diarrhea is defined as the time elapsing (in hours rounded up from minutes \> 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement \[UBM\] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, \> 50% reduction in number of stools or \> 75% reduction in volume of liquid stool) that are sustained through to TOC.
Time frame: Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
For participants with clinical response at TOC, recurrence of CDI is defined as re-establishment of diarrhea after TOC to an extent (judged by the frequency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy.
Time frame: Day 40, 55, 90
Time to Recurrence of CDI after End of Active Treatment
Time to recurrence of CDI is defined as the time in days from clinical response until onset of recurrence of CDI for participants who respond at TOC.
Time frame: From day 10 up to day 90
Disease-free Survival After Day 10
Disease-free survival is defined as the time in days a participant does not have symptoms of diarrhea from day 10 up to day 90 for participants who respond at TOC.
Time frame: From day 10 up to day 90