Bezlotoxumab Versus FMT for Multiple Recurrent CDI
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
The objective of this trial is to investigate whether a treatment strategy offering
bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal
efficacy compared with a treatment strategy with initial FMT. Strategy A includes
bezlotoxumab as ancillary treatment as first option, and FMT in case of failure. Option B
includes FMT as ancillary treatment as first option, and antibiotic treatment with
fidaxomicin in case of failure. A secondary objective is to provide a point estimate of
recurrence after bezlotoxumab for the treatment of multiple recurrent CDI.
Phase:
Phase 4
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Erasmus Medical Center Medical Center Haaglanden OLVG