Inflammatory Bowel Disease (IBD) Clinical Trial
Official title:
Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin
(FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C.
difficile Infection (CDI).
This study will also compare CDI clinical response to the microbiological response in terms
of magnitude of reduction of C. difficile total viable count and spore count during treatment
with FDX and if achieved; the time to microbial eradication; determine time to negative CDI
toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of
FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay,
readmissions and resource utilization for IBD patients receiving FDX; record the incidence
and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life
as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.
n/a
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