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

Who is this study for? Patients with multiple recurrent clostridioides difficile infection
What treatments are being studied? Bezlotoxumab+Vancomycin
Status: Not yet recruiting
Location: See all (4) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4

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.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: No

• 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

Other Locations
Amsterdam University Medical Centers, AMC
Haaglanden Medical Center
Den Haag
Leiden University Medical Center
Erasmus Medical Center
Contact Information
J van Prehn
0031 (0)71 52 63931
Time Frame
Start Date: January 2022
Estimated Completion Date: December 2024
Target number of participants: 66
Experimental: Strategy A: initial SoC + bezlotoxumab. SoC + FMT rescue therapy.
initial bezlotoxumab in addition to 14 days SoC oral antibiotic treatment with vancomycin 125 mg QID. 14 days of vancomycin 125mg QID plus fecal microbiota in case of treatment failure.
Active Comparator: Strategy B: initial SoC + FMT. Fidaxomicin rescue therapy.
fecal microbiota transplantation in addition to 14 days SoC oral antibiotic treatment with vancomycin 125 mg QID. 10 days of fidaxomicin 200 mg BID in case of treatment failure.
E J Kuijper, M MC Lambregts, J van Prehn, E M Terveer
Collaborators: Medical Center Haaglanden, Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), OLVG
Leads: Leiden University Medical Center

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