Microbiota-based Drug RBX2660 is Efficacious and Safe in Patients with Recurrent Clostridium difficile Infections

Robert Orenstein DO, Erik Dubberke MD MSPH, Sahil Khanna MBBS, Gail Hecht MD, Herbert L. Dupont MD, Christine H. Lee MD, Dale N. Gerding MD, Ken Blount PhD

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Effective treatment options for recurrent C. difficile infection (rCDI) are limited
High recurrence rates are associated with current standard of care
Microbiota-based therapies are being developed and evaluated in clinical trials
Here we collectively present results from two Phase 2 controlled trials to evaluate the safety and efficacy of RBX2660

Inclusion criteria: >18 years old with documentation of either 2 recurrences after a primary episode and has 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
Exclusion criteria: History of irritable bowel disease (ulcerative colitis, Crohn’s disease or microscopic colitis); irritable bowel syndrome; chronic diarrhea; celiac disease; colostomy; evidence of active colitis; known exposure to antibiotics within 6 months after study enrollment; compromised immune system (white blood cell count<1000 cells/μL)
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 the last treatment. Patients were classified as a treatment failure if all four (4) of the following criteria were met: recurrence of diarrhea less than 8 weeks after administration of the last assigned study enema, a positive laboratory diagnosis of C. difficile as conducted and reported by the study investigator, a need for retreatment for CDI, and no other cause for diarrhea