Cargando…

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

BACKGROUND: Recurrent Clostridioides difficile infection, associated with dysbiosis of gut microbiota, has substantial disease burden in the USA. RBX2660 is a live biotherapeutic product consisting of a broad consortium of microbes prepared from human stool that is under investigation for the reduct...

Descripción completa

Detalles Bibliográficos
Autores principales:	Khanna, Sahil, Assi, Maha, Lee, Christine, Yoho, David, Louie, Thomas, Knapple, Whitfield, Aguilar, Humberto, Garcia-Diaz, Julia, Wang, Gary P., Berry, Scott M., Marion, Joe, Su, Xin, Braun, Tricia, Bancke, Lindy, Feuerstadt, Paul
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2022
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607700/ https://www.ncbi.nlm.nih.gov/pubmed/36287379 http://dx.doi.org/10.1007/s40265-022-01797-x

Ejemplares similares

Publisher Correction: 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
por: Khanna, Sahil, et al.
Publicado: (2022)

Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
por: Tillotson, Glenn, et al.
Publicado: (2022)

522. Significant Improvement in Health-Related Quality of Life (HRQL) with RBX2660: Results from a Phase 3 Randomized, Placebo-Controlled Trial in Recurrent Clostridioides Difficile Infection (PUNCH CD3)
por: Feuerstadt, Paul, et al.
Publicado: (2022)

Retrospective Analysis of the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA(TM)) Administered Under Enforcement Discretion to Patients With Clostridioides difficile Infection
por: Feuerstadt, Paul, et al.
Publicado: (2023)

167. Efficacy of Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data from Five Prospective Clinical Studies
por: Bancke, Lindy, et al.
Publicado: (2021)

236. Treatment of Recurrent Clostridioides difficile Infection With RBX2660 in Patients ≥ 65 Years Old With Underlying Comorbidities
por: Tillotson, Glenn S, et al.
Publicado: (2022)

Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial
por: Orenstein, Robert, et al.
Publicado: (2022)

The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660
por: Orenstein, Robert
Publicado: (2022)

1039. Rapid Restoration of Bile Acid Compositions After Treatment with RBX2660 for Recurrent Clostridioides difficile Infection—Results from the PUNCH CD3 Phase 3 Trial
por: Papazyan, Romeo, et al.
Publicado: (2021)

Safety of fecal microbiota, live-jslm (REBYOTA(™)) in individuals with recurrent Clostridioides difficile infection: data from five prospective clinical trials
por: Lee, Christine, et al.
Publicado: (2023)

Final Results from a Phase 2b Randomized, Placebo-Controlled Clinical Trial of RBX2660: A Microbiota-Based Drug for the Prevention of Recurrent Clostridioides difficile Infection
por: Dubberke, Erik R., et al.
Publicado: (2022)

1042. Safety of Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data from Five Prospective Clinical Studies
por: Braun, Tricia, et al.
Publicado: (2021)

Successful Response to Microbiota-Based Drug RBX2660 in Patients with Recurrent Clostridium Difficile Infection is Associated with More Pronounced Alterations in Microbiome Profile
por: Khanna, Sahil, et al.
Publicado: (2017)

468 RBX2660 (microbiota suspension) for Recurrent C. difficile Infection: 60-Day Interim Analysis of the PUNCH-CD Phase 2 Safety Study
por: Dubberke, Erik, et al.
Publicado: (2014)

LB5. A Long-Time Coming: Final 2-year Analysis of Efficacy, Durability, and Microbiome Changes in a Controlled Open-Label Trial of Investigational Microbiota-Based Drug RBX2660 for Recurrent Clostridioides difficile Infections
por: Orenstein, Robert, et al.
Publicado: (2019)

129. Antimicrobial Resistance Genes Were Reduced Following Administration of Investigational Microbiota-Based Live Biotherapeutic RBX2660 to Individuals with Recurrent Clostridioides difficile Infection
por: Hau, Heidi, et al.
Publicado: (2021)

669. Twelve-Month Durability of Microbiota-Based Therapy RBX2660 for Prevention of Recurrent Clostridium difficile Infection
por: Jones, Courtney, et al.
Publicado: (2019)

Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial
por: Garey, Kevin W, et al.
Publicado: (2023)

670. VRE Clearance in Patients with Recurrent Clostridium difficile Infection Following Treatment with Microbiota-Based Drug RBX2660
por: Hau, Heidi, et al.
Publicado: (2019)

1950. Prevention of Recurrent Clostridium difficile at Six Months Following Treatment With Microbiota-Based Therapy RBX2660: Durability Results From a Phase 2 Open-Label Study
por: Mische, Sarah, et al.
Publicado: (2018)

1064. Treatment Success in Reducing Recurrent Clostridioides difficile Infection with Investigational Live Biotherapeutic RBX2660 Is Associated with Microbiota Restoration: Consistent Evidence from a Phase 3 Clinical Trial
por: Blount, Ken, et al.
Publicado: (2021)

29. Rapid Restoration of Bile Acid Compositions After Treatment with Investigational Microbiota-based Therapeutic RBX2660 for Recurrent clostrioides Difficile Infection
por: Ferdyan, Nicky, et al.
Publicado: (2020)

Heterogeneity of Randomized Controlled Trials of Fecal Microbiota Transplantation in Recurrent Clostridioides difficile Infection
por: Feuerstadt, Paul, et al.
Publicado: (2021)

RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients’ Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections
por: Khanna, Sahil, et al.
Publicado: (2020)

Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial
por: Kwak, Suryang, et al.
Publicado: (2020)

Management of Clostridioides difficile colitis: insights for the gastroenterologist
por: Saha, Srishti, et al.
Publicado: (2019)

Management of Clostridioides difficile infection in patients with inflammatory bowel disease
por: Khanna, Sahil
Publicado: (2021)

Clostridioides difficile infection: curbing a difficult menace
por: Khanna, Sahil, et al.
Publicado: (2022)

Immune response against Clostridioides difficile and translation to therapy
por: Sehgal, Kanika, et al.
Publicado: (2021)

Evolution of clinical guidelines for antimicrobial management of Clostridioides difficile infection
por: Chaar, Abdelkader, et al.
Publicado: (2021)

The interplay of Clostridioides difficile infection and inflammatory bowel disease
por: Sehgal, Kanika, et al.
Publicado: (2021)

The interplay of SARS-CoV-2 and Clostridioides difficile infection
por: Khanna, Sahil, et al.
Publicado: (2021)

Restoration of Bacterial Microbiome Composition and Diversity Among Treatment Responders in a Phase 2 Trial of RBX2660: An Investigational Microbiome Restoration Therapeutic
por: Blount, Ken F, et al.
Publicado: (2019)

366. Association Between Gut Microbiota and Health-Related Quality of Life in Patients with Recurrent Clostridioides difficile Infection: Results from the PUNCH CD3 Clinical Trial
por: Feuerstadt, Paul, et al.
Publicado: (2023)

Transitions of care in Clostridioides difficile infection: a need of the hour
por: Khanna, Sahil, et al.
Publicado: (2022)

Gut microbiome and Clostridioides difficile infection: a closer look at the microscopic interface
por: Sehgal, Kanika, et al.
Publicado: (2021)

Microbiome Restoration by RBX2660 Does Not Preclude Recurrence of Multidrug-Resistant Urinary Tract Infection Following Subsequent Antibiotic Exposure: A Case Report
por: Keen, Eric C, et al.
Publicado: (2020)

The role of the gut microbiome in colonization resistance and recurrent Clostridioides difficile infection
por: Seekatz, Anna Maria, et al.
Publicado: (2022)

Improving Stewardship of Clostridioides difficile Testing with EMR and Provider Phone Calls
por: Joslin, Joseph, et al.
Publicado: (2022)

The Effect of a Clinical Pathway on Reducing the Rate of Healthcare-Onset Clostridioides difficile
por: Millard, John W., et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_efmasv4vpmq7oap5dgs7t70nl4