| Related Articles |
Safety and Durability of RBX2660 (microbiota suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study.
Clin Infect Dis. 2015 Nov 12;
Authors: Orenstein R, Dubberke E, Hardi R, Ray A, Mullane K, Pardi DS, Ramesh MS, PUNCH CD Investigators
Abstract
BACKGROUND: Managing recurrent Clostridium difficile infection (CDI) presents a significant challenge for clinicians and patients. Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent CDI, yet availability of a standardized, safe and effective product has been lacking. The aim of this study was to assess the safety and effectiveness of RBX2660 (microbiota suspension), a commercially prepared FMT drug manufactured using standardized processes and available in a ready-to-use format.
METHODS: Patients with at least 2 recurrent CDI episodes or at least 2 severe episodes resulting in hospitalization were enrolled in a prospective, multicenter open-label study of RBX2660 administered via enema. Intensive surveillance for adverse events (AEs) was conducted daily for 7 days following treatment and then at 30 days, 60 days, 3 months and 6 months. The primary objective was product-related AEs. A secondary objective was CDI-associated diarrhea resolution at 8 weeks.
RESULTS: Of the 40 patients enrolled at 11 centers in the U.S. between August 15 and December 16, 2013, 34 received at least one dose of RBX2660, and 31 completed 6-month follow-up. Overall efficacy was 87.1% (16 with one dose and 11 with two doses). Of 188 reported AEs, diarrhea, flatulence, abdominal pain/cramping and constipation were most common. The frequency and severity of AEs decreased over time. Twenty serious AEs were reported in 7 patients; none were related to RBX2660 or its administration.
CONCLUSIONS: Among patients with recurrent or severe CDI, administration of RBX2660 via enema appears to be safe and effective.
PMID: 26565008 [PubMed - as supplied by publisher]