2024
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
Kraft C, Sims M, Silverman M, Louie T, Feuerstadt P, Huang E, Khanna S, Berenson C, Wang E, Cohen S, Korman L, Lee C, Kelly C, Odio A, Cook P, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi D, Hasson B, McGovern B, von Moltke L, Pardi D. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infectious Diseases And Therapy 2024, 13: 2105-2121. PMID: 38941068, PMCID: PMC11416444, DOI: 10.1007/s40121-024-01007-z.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase 3 trialRCDI rateAnalysis of treatment-emergent adverse eventsTreatment-related treatment-emergent adverse eventsStandard-of-care antibioticsHigh-risk patientsClostridioides difficile infectionPreventing rCDIRenal impairment/failureAbdominal painRecurrent CDIEfficacy analysisAdverse eventsTreatment-relatedPrevent recurrencePrevalent comorbiditiesRCDIWeeksAntibioticsPatientsComorbiditiesEfficacyPlaceboMicrobiome
2023
The real efficacy of microbiota restoration following standard of care antimicrobial in patients with recurrent Clostridiodes difficile
Sehgal K, Feuerstadt P. The real efficacy of microbiota restoration following standard of care antimicrobial in patients with recurrent Clostridiodes difficile. Translational Gastroenterology And Hepatology 2023, 8: 31-31. PMID: 38021361, PMCID: PMC10643224, DOI: 10.21037/tgh-23-46.Peer-Reviewed Original Research