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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02254967
Other study ID # 2819-MA-1002
Secondary ID 2013-004619-31
Status Completed
Phase Phase 4
First received
Last updated
Start date November 6, 2014
Est. completion date May 5, 2016

Study information

Verified date November 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fidaxomicin
oral tablets administered in an extended pulsed regimen
Vancomycin
oral capsule

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Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Europe Ltd. Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

Austria,  Belgium,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Poland,  Portugal,  Romania,  Russian Federation,  Slovenia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Secondary 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. Day 40, 55, 90
Secondary 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. Day 12, 27
Secondary Percentage of Participants with a Clinical Response of CDI at Day 12 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. Day 12
Secondary 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). Baseline through day 90
Secondary 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. Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
Secondary 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. Day 40, 55, 90
Secondary 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. From day 10 up to day 90
Secondary 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. From day 10 up to day 90
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