The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
On Day 1, subjects with diarrhea defined as having three or more unformed bowel movements or \>200 mL of unformed stool (for subjects having rectal collection devices) within 24 hours, confirmed by a rapid CDI test (positive for both toxins A \& B and glutamate dehydrogenase) to have CDI will be randomized to receive fidaxomicin or vancomycin (1:1 randomization). Subjects will be treated with study medication from Day 1 to Day 10. Assessment for clinical cure (Test of Cure \[TOC\]) will take place 48 - 72 hours after End of Treatment (EOT). Subjects not meeting the definition of clinical cure at TOC will be defined as treatment failures. A stool sample for evaluation of microbial cure will be taken at TOC on Day 12. Subjects meeting the criteria for clinical cure at TOC will be monitored for recurrence until 28 days after TOC (Day 40). Treatment of subjects with recurrence of CDI will be at the discretion of the Investigator. Subjects not meeting the criteria for clinical cure at TOC will be followed for safety until Day 40. Further CDI treatment will be at the discretion of the Investigator. The strain of Clostridium difficile will be determined for all samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Univ. Klinik für Innere Medizi
Salzburg, Austria
Herlev University Hospital
Herlev, Denmark
Institut Curie
Paris, France
Sustained clinical cure of CDI at day 26
Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either: * ≤3 unformed bowel movements for two consecutive days * ≥50% reduction in the number of unformed bowel movements compared to baseline; or * 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
Time frame: Day 26
Clinical Cure of CDI
Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either: * ≤3 unformed bowel movements for two consecutive days * ≥50% reduction in the number of unformed bowel movements compared to baseline; or * 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
Time frame: Day 12
Sustained Clinical Cure of CDI at day 40
Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either: * ≤3 unformed bowel movements for two consecutive days * ≥50% reduction in the number of unformed bowel movements compared to baseline; or * 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
Time frame: Day 40
Microbial Eradication
Total viable count of clostridium difficile recovered from fecal specimen is below the limit of detection
Time frame: Day 12
Resolution of diarrhea
First of two days with \<3 bowel movements per day
Time frame: Day 12
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Hôpital Necker
Paris, France
Charité
Berlin, Germany
Klinik I für Innere Medizin
Cologne, Germany
Universitätsklinikum
Essen, Germany
Universitätsklinikum Halle
Halle, Germany
General Hospital of Athens
Athens, Greece
Laiko General Hospital
Athens, Greece
...and 6 more locations
Use of further CDI therapy required
Time frame: Between Day 10 and Day 12
Number of unformed stools
Time frame: Between Day 10 and Day 12
>50% reduction in number of unformed stools compared to baseline
Time frame: Day 1 to Day 12
Recurrence of CDI
After TOC, re-establishment of diarrhea to an extent that is greater than the frequency recorded on the last day of study medication
Time frame: Between Day 1 and Day 40
Time to recurrence of CDI
Time elapsing (days) from TOC to confirmed recurrence of CDI
Time frame: Between Day 12 and Day 40