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Erik R Dubberke, Christine H Lee, Robert Orenstein, Sahil Khanna, Gail Hecht, Dale N Gerding
Background: Despite advancements, recurrent Clostridium difficile infections (CDI) remain an urgent public health threat with insufficient response rates to currently-approved antibiotic therapies. Microbiota-based treatments appear effective, but rigorous clinical trials are required to optimize dosing strategies and substantiate long-term safety. Methods: This randomized, double-blind, placebo-controlled Phase 2B trial (NCT02299570) enrolled adult patients with two or more CDI recurrences to receive: two doses of RBX2660, a standardized microbiota-based drug (Group A); two doses of placebo (Group B); or one dose of RBX2660 followed by one dose of placebo (Group C)...
March 29, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
John P Mills, Krishna Rao, Vincent B Young
PURPOSE OF REVIEW: Probiotics may prevent Clostridium difficile infection (CDI), a leading healthcare-associated infection in the United States. However, prior studies were limited by heterogeneity in products and patient populations. Recent clinical evidence and new approaches to probiotic development are reviewed. RECENT FINDINGS: Probiotic use may reduce incident CDI in high-risk populations by as much as 50%, though prior clinical trials have yielded conflicting results...
January 2018: Current Opinion in Gastroenterology
Jessica Martin, Mark Wilcox
PURPOSE OF REVIEW: Clostridium difficile infection has attained high prominence given its prevalence and impacts on patients and healthcare institutions. Multiple new approaches to the prevention and treatment of C. difficile infection (CDI) are undergoing clinical trials. RECENT FINDINGS: Bezlotoxumab is a monoclonal antibody against toxin B that has successfully completed phase III studies, demonstrating a significant reduction in recurrent CDI when given with standard of care antibiotics...
December 2016: Current Opinion in Infectious Diseases
Erik R Dubberke, Kathleen M Mullane, Dale N Gerding, Christine H Lee, Thomas J Louie, Harriet Guthertz, Courtney Jones
Background.  Vancomycin-resistant Enterococcus (VRE) is a major healthcare-associated pathogen and a well known complication among transplant and immunocompromised patients. We report on stool VRE clearance in a post hoc analysis of the Phase 2 PUNCH CD study assessing a microbiota-based drug for recurrent Clostridium difficile infection (CDI). Methods.  A total of 34 patients enrolled in the PUNCH CD study received 1 or 2 doses of RBX2660 (microbiota suspension). Patients were requested to voluntarily submit stool samples at baseline and at 7, 30, and 60 days and 6 months after the last administration of RBX2660...
September 2016: Open Forum Infectious Diseases
Arnab Ray, Courtney Jones
AIM: To evaluate the impact of the donor material versus the patient in outcomes achieved with RBX2660, a microbiota-based drug under study for recurrent Clostridium difficile infection (CDI). METHODS: RBX2660 was administered to patients enrolled in the previously reported Phase II PUNCH CD study under Rebiotix's Investigational New Drug submission to the US FDA. Four donors were used to prepare the RBX2660 drug product used in the study. The product was manufactured in individual, donor-specific batches that could be tracked to individual patients and their outcomes...
May 2016: Future Microbiology
Robert Orenstein, Erik Dubberke, Robert Hardi, Arnab Ray, Kathleen Mullane, Darrell S Pardi, Mayur S Ramesh
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. Our aim in 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...
March 1, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
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