S132 An Interim Analysis of a Phase 3, Open-Label Study Indicates Efficacy and Safety of RBX2660 in Patients With Recurrent Clostridioides difficile Infection

Khanna, Sahil; Dubberke, Erik R.; Knapple, Whitfield L.; Feuerstadt, Paul; Assi, Maha; Ng, Samson; Guthmueller, Beth

doi:10.14309/01.ajg.0000857168.31201.9f

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Phase 3b Open-label Trial1

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2024

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Cited by 5 publications

(1 citation statement)

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“…The response was sustained in 84% of patients at 6 months. Most adverse events were mild to moderate and were gastrointestinal in nature, with diarrhea and abdominal pain most reported (21).…”

Section: Phase 3b Open-label Trialmentioning

confidence: 99%

Prescription Microbiome Therapeutic for Recurrent Clostridioides difficile Infection: Fecal Microbiota Live-jslm

Oneto,

Khanna

2024

Am J Gastroenterol

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Section: Phase 3b Open-label Trialmentioning

confidence: 99%

Prescription Microbiome Therapeutic for Recurrent Clostridioides difficile Infection: Fecal Microbiota Live-jslm

Oneto,

Khanna

2024

Am J Gastroenterol

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European Practice for CDI Treatment

Fitzpatrick,

Brennan,

van Prehn

et al. 2024

Advances in Experimental Medicine and Biology

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Clostridium difficile infection (CDI) remains a significant cause of morbidity and mortality worldwide. Historically, two antibiotics (metronidazole and vancomycin) and a recent third (fidaxomicin) have been used routinely for CDI treatment; convincing data are now available showing that metronidazole is the least efficacious agent. The European Society of Clinical Microbiology and Infectious Diseases CDI treatment guidelines outline the treatment options for a variety of CDI clinical scenarios, including use of the more traditional anti-CDI therapies (e.g., metronidazole, vancomycin), the role of newer anti-CDI agents (e.g., fidaxomicin), indications for surgical intervention and for non-antimicrobial management (e.g., faecal microbiota transplantation, FMT). A 2017 survey of 20 European countries found that while the majority (n=14) have national CDI guidelines that provide a variety of recommendations for CDI treatment, only five have audited guideline implementation. A variety of restrictions are in place in 13 (65%) countries prior to use of new anti-CDI treatments, including committee/infection specialist approval or economic review/restrictions. Novel anti-CDI agents are being evaluated in Phase III trials; it is not yet clear what will be the roles of these agents. Prophylaxis is an optimum approach to reduce the impact of CDI especially in high-risk populations; monoclonal antibodies, antibiotic blocking approaches and multiple vaccines are currently in advanced clinical trials. The treatment of recurrent CDI is particularly troublesome, and several different live bio therapeutics are being developed, in addition to FMT.

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RBX2660 (REBYOTA®) in preventing recurrence of Clostridioides difficile infection: a profile of its use in the USA

Blair

2023

Drugs Ther Perspect

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S132 An Interim Analysis of a Phase 3, Open-Label Study Indicates Efficacy and Safety of RBX2660 in Patients With Recurrent Clostridioides difficile Infection

Cited by 5 publications

References 0 publications

Prescription Microbiome Therapeutic for Recurrent Clostridioides difficile Infection: Fecal Microbiota Live-jslm

Prescription Microbiome Therapeutic for Recurrent Clostridioides difficile Infection: Fecal Microbiota Live-jslm

European Practice for CDI Treatment

RBX2660 (REBYOTA®) in preventing recurrence of Clostridioides difficile infection: a profile of its use in the USA

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