Cargando…
Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial
IMPORTANCE: A safe and effective treatment for recurrent Clostridioides difficile infection (CDI) is urgently needed. Antibiotics kill toxin-producing bacteria but do not repair the disrupted microbiome, which promotes spore germination and infection recurrence. OBJECTIVES: To evaluate the safety an...
Autores principales: | Sims, Matthew D., Khanna, Sahil, Feuerstadt, Paul, Louie, Thomas J., Kelly, Colleen R., Huang, Edward S., Hohmann, Elizabeth L., Wang, Elaine E. L., Oneto, Caterina, Cohen, Stuart H., Berenson, Charles S., Korman, Louis, Lee, Christine, Lashner, Bret, Kraft, Colleen S., Ramesh, Mayur, Silverman, Michael, Pardi, Darrell S., De, Ananya, Memisoglu, Asli, Lombardi, David A., Hasson, Brooke R., McGovern, Barbara H., von Moltke, Lisa |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926325/ https://www.ncbi.nlm.nih.gov/pubmed/36780159 http://dx.doi.org/10.1001/jamanetworkopen.2022.55758 |
Ejemplares similares
-
Integrated efficacy analysis from phase 3 studies of investigational microbiome therapeutic, SER-109, in recurrent Clostridioides difficile infection
por: Sims, Matthew, et al.
Publicado: (2023) -
Prevalence of Comorbid Factors in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Randomized Trial of an Oral Microbiota–Based Therapeutic
por: Berenson, Charles S, et al.
Publicado: (2023) -
Integrated safety analysis of phase 3 studies for investigational microbiome therapeutic, SER-109, in recurrent CDI
por: Sims, Matthew, et al.
Publicado: (2023) -
655. Analysis of Microbiome Diversity and Secondary Bile Acid Synthesis Following SER-109 or Placebo in Patients with First Recurrent or Multiply Recurrent Clostridioides difficile Infection
por: Kelly, Colleen R, et al.
Publicado: (2023) -
658. Diagnostic Testing Among Patients with Suspected Recurrent Clostridioides difficile Infection (rCDI) in ECOSPOR III a Phase 3 Clinical Trial: Implications for Clinical Practice vs Clinical Trials
por: Sims, Matthew, et al.
Publicado: (2021)