Highlights
- •C. difficile infections (CDI) are potentially deadly and serious infections.
- •Around 35% of CDI cases recur despite antibiotic treatment.
- •This meta-analysis pooled 580 participants across 6 trials.
- •Odds ratio of 1.82 (95% CI = 1.37–2.41) was reported favoring fecal microbiota use.
- •In-treatment group efficacy was 72% (95% CI = 68–76%).
Abbreviations:
CDI (Clostridioides Difficile Infection), CI (Confidence Interval), DF (Degrees of Freedom), FDA (Food and Drug Administration)To read this article in full you will need to make a payment
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References
FDA. November 30, 2022 Summary Basis for Regulatory Action - REBYOTA. 2022. Available from: https://www.fda.gov/media/163879/download#:∼:text=The%20requested%20indication%20for%20REBYOTA,combination%20product%20for%20rectal%20administration. Accessed December 10, 2022.
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- Efficacy and safety of RBX2660 in PUNCH CD3, a Phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection.Drugs. 2022; 82: 1527-1538https://doi.org/10.1007/s40265-022-01797-x
- Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial.BMC Infect Dis. 2022; 22: 1-13https://doi.org/10.1186/s12879-022-07256-y
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- Restoration of bacterial microbiome composition and diversity among treatment responders in a phase 2 trial of RBX2660: an investigational microbiome restoration therapeutic.Open forum Infect Dis. 2019; 6 (Oxford University Press US): ofz095https://doi.org/10.1093/ofid/ofz095
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Article info
Publication history
Published online: December 28, 2022
Accepted:
December 22,
2022
Received in revised form:
December 19,
2022
Received:
December 14,
2022
Publication stage
In Press Corrected ProofFootnotes
Authorship Note: All authors have contributed equally. Dr. Zouina Sarfraz is the guarantor of this meta-analysis.
Identification
Copyright
© 2022 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
