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Bezlotoxumab Versus FMT for Multiple Recurrent CDI

NCT05077085 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-03-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • OLVG

    collaborator NETWORK

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Medical Center Haaglanden

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • J van Prehn · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2024-07-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077085 on ClinicalTrials.gov