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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
CDI is confirmed by clinical symptoms and rapid CDI test
Subject has not been treated with medication for CDI within the last 10 days
Subject is:
Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study
Male and female subjects that are sexually active must agree to practice effective birth control during the study and for 30 days after the end of the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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