Bezlotoxumab Versus FMT for Multiple Recurrent CDI

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2022

Primary Completion Date

July 31, 2024

Study Completion Date

December 31, 2024

Conditions
Clostridium InfectionsClostridioides DifficileEnterocolitis, 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)

Trial Locations (4)

Unknown

Amsterdam University Medical Centers, AMC, Amsterdam

Leiden University Medical Center, Leiden

Erasmus Medical Center, Rotterdam

Haaglanden Medical Center, The Hague

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

OLVG

NETWORK

collaborator

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

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

Medical Center Haaglanden

OTHER

lead

Leiden University Medical Center

OTHER

NCT05077085 - Bezlotoxumab Versus FMT for Multiple Recurrent CDI | Biotech Hunter | Biotech Hunter