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Bezlotoxumab Versus FMT for Multiple Recurrent CDI — BSTEP  

Clostridium Infections Clinical Trial

Official title:
New Treatment Strategy for Patients With Multiple Recurrent Clostridioides Difficile Infection With Bezlotoxumab as First Option

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05077085
Study type Interventional
Source Leiden University Medical Center
Contact
Status Withdrawn
Phase Phase 4
Start date January 2022
Completion date December 2024
View Details
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