Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
Infectious Diseases and Therapy, ISSN: 2193-6382, Vol: 13, Issue: 10, Page: 2105-2121
2024
- 22Usage
- 1Captures
- 1Mentions
Metric Options: CountsSelecting the 1-year or 3-year option will change the metrics count to percentiles, illustrating how an article or review compares to other articles or reviews within the selected time period in the same journal. Selecting the 1-year option compares the metrics against other articles/reviews that were also published in the same calendar year. Selecting the 3-year option compares the metrics against other articles/reviews that were also published in the same calendar year plus the two years prior.
Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Usage22
- Downloads18
- Abstract Views4
- Captures1
- Readers1
- Mentions1
- News Mentions1
- News1
Article Description
Introduction: Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI. Objective, Design, and Patients: To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities. Methods: VOS or placebo [ECOSPOR III only] (4 capsules once daily for 3 days). Integrated analysis of treatment-emergent adverse events (TEAEs) collected through week 8; serious TEAEs and TEAEs of special interest collected through week 24; and rates of rCDI (toxin-positive diarrhea requiring treatment) evaluated through weeks 8 and 24. Results: TEAEs were mostly mild or moderate and gastrointestinal. Most common treatment-related TEAEs were flatulence, abdominal pain and distension, fatigue, and diarrhea. There were 11 deaths (3.2%) and 48 patients (13.8%) with serious TEAEs, none treatment-related. The rCDI rate through week 8 was 9.5% (95% CI 6.6–13.0) and remained low through 24 weeks (15.2%; 95% CI 11.6–19.4). Safety and rCDI rates were consistent across subgroups including age, renal impairment/failure, diabetes, and immunocompromise/immunosuppression. Conclusions: VOS was well tolerated and rates of rCDI remained low through week 24 including in those with comorbidities. These data support the potential benefit of VOS following antibiotics to prevent recurrence in high-risk patients. Trial Registration: ClinicalTrials.gov identifier, NCT03183128 and NCT03183141.
Bibliographic Details
https://scholarlyworks.beaumont.org/infectious_diseases_articles/88; https://digitalcommons.library.tmc.edu/baylor_docs/190; https://scholarlyworks.beaumont.org/infectious_diseases_articles/82
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85204738851&origin=inward; http://dx.doi.org/10.1007/s40121-024-01007-z; http://www.ncbi.nlm.nih.gov/pubmed/38941068; https://clinicaltrials.gov/ct2/show/NCT03183128; https://link.springer.com/10.1007/s40121-024-01007-z; https://scholarlyworks.beaumont.org/infectious_diseases_articles/88; https://scholarlyworks.beaumont.org/cgi/viewcontent.cgi?article=1086&context=infectious_diseases_articles; https://digitalcommons.library.tmc.edu/baylor_docs/190; https://digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=1189&context=baylor_docs; https://scholarlyworks.beaumont.org/infectious_diseases_articles/82; https://scholarlyworks.beaumont.org/cgi/viewcontent.cgi?article=1080&context=infectious_diseases_articles; https://dx.doi.org/10.1007/s40121-024-01007-z; https://link.springer.com/article/10.1007/s40121-024-01007-z
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