NCT05077085

Bezlotoxumab Versus FMT for Multiple Recurrent CDI

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Infections
• Clostridioides Difficile
• Enterocolitis, Pseudomembranous

Interventions

Type	Name	Description
DRUG	Bezlotoxumab	single intravenous infusion of bezlotoxumab 10 mg/kg
PROCEDURE	Fecal Microbiota Transplantation (FMT)	single infusion of 198 cc fecal suspension (derived from 60g donor feces) via duodenal tube or coloscopy
DRUG	Vancomycin oral	14 days vancomycin oral 125mg QID (250mg QID when 125mg not available)

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2021-10-13
• Last updated: 2023-03-28

Locations

4 sites across 1 country: Netherlands