drugset / Trial / NCT05077085
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
Phase 4
Withdrawn
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabErasmus Medical Center · collabMedical Center Haaglanden · collabOLVG · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-01
- Primary completion
- 2024-07
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bezlotoxumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Vancomycin | Other / unclassified | 125 mg | Oral |
| Background | Vancomycin | Other / unclassified | 250 mg | Oral |