Successful Implementation of a Phase 2 Study of a Novel Microbiota-based drug for Recurrent Clostridium difficile Infection

Kathy Tracey, LPN, CCRC, Manager of Clinical Research, Chevy Chase Clinical Research, Chevy Chase, MD

Implementation of a Phase 2 Study of a Novel Microbiota-based Drug for Recurrent Clostridium difficile Infection

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Society of Gastroenterology Nurses and Associates
May 15–19, 2015, Baltimore, MD

Poster Abstract

Clostridium difficile is a leading cause of healthcare acquired infection. Cases are growing and increasing in virulence. Treatment of recurrent Clostridium difficile infection is especially challenging, and no drugs are currently indicated for the condition. PUNCH CD was a Phase 2 study of the safety and efficacy of RBX2660 (microbiota suspension). RBX2660 is the first in a new category of non-antibiotic drugs consisting of a suspension of live human-derived intestinal microbes. Of the 13 centers in the study, we were the top-enrolling center with 8/40 patients (20%). Patient were very receptive to the study – not a single eligible patient refused screening. We attribute our success to close involvement in protocol review and site training as well as self-education about a new treatment modality and to a recruitment campaign that utilized our referral network and social media tools. Other factors were patient education to manage expectations and follow-up compliance and the availability of the drug in a ready-to-use enema format. We were able to conduct this study with minimal disruption to the clinic routine; learnings will be carried forward to future studies.