Effective treatment options for recurrent C. difficile infection (rCDI) are limited.
High recurrence rates are associated with current standard-of-care antibiotic therapy.
Microbiota-based therapies are being developed and evaluated in clinical studies.
RBX2660 has shown efficacy in preventing rCDI at 8 weeks in a randomized, blinded, placebo-controlled Phase 2B trial (PUNCH CD2; NCT02299570).
Here we report RBX2660 durability beyond the initial primary clinical end-point of a subsequent Phase 2 openlabel study (NCT02589847), demonstrating rCDI prevention at 6 months post-treatment.
Clinical Trial Design
Inclusion criteria: >18 years old with documentation of either 2 recurrences after a primary episode and had completed at least two rounds of standard-of-care oral antibiotic therapy, or at least 2 episodes of severe CDI resulting in hospitalization; a positive stool test for the presence of toxigenic C. difficile within 60 days prior to enrollment.
Antibiotics were discontinued 24-48 hours prior to the first enema.
Safety was assessed in clinic at 1, 4, and 8 weeks and via telephone at 2, 3, between 5-7 weeks, and at 3, 6, 12 and 24 months.
Success was defined as the absence of CDI at 8 weeks following completion of last treatment. Subjects were classified as treatment failures if all 4 criteria were met (recurrence of diarrhea <8 weeks after delivery of treatment, positive laboratory C. difficile diagnosis, requirement of retreatment and no other cause for diarrhea).