Bezlotoxumab Versus FMT for Multiple Recurrent CDI

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Erasmus Medical Center; Medical Center Haaglanden; OLVG
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• 18-90 years old

• diarrhea (3 or more unformed stools per 24h for two consecutive days; or >= 8 unformed stools per 48h) XML File Identifier: KqQEbBLRYEZjGgsIl5GcI+NXCyM= Page 10/22

• positive PCR test for toxin A/B genes and/or positive toxin EIA for current and previous episodes (low PCR cycle threshold value when only PCR performed)

• a minimum of two prior CDI episodes

• previous episode is maximum of 3 months prior to the current episode

• the current episode responds well to Standard of Care treatment (vancomycin or fidaxomicin orally).

• Assessment of the severity of the disease will be performed according to the ESCMID recommendations.

• Both mild and severe CDI will be included

Exclusion Criteria:

• Severe complicated CDI, i.e presence of: hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, bowel perforation, or any fulminant course of disease.

• ICU admission for underlying disease

• pregnancy or current desire for pregnancy

• breastfeeding

• (prolonged) use of antibiotics (other than for treatment of CDI) during the study period or directly after the intervention

• previous use of bezlotoxumab or fecal microbiota transplantation

• a history of underlying congestive heart failure (potential safety signal phase-III trail bezlotoxumab).

• Diagnosis of inflammatory bowel disease in medical history.