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240 results

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A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile Infection: Clinical Outcomes With Microbiome and Metabolome Correlates of Response.
Okhuysen PC, Ramesh MS, Louie T, Kiknadze N, Torre-Cisneros J, de Oliveira CM, Van Steenkiste C, Stychneuskaya A, Garey KW, Garcia-Diaz J, Li J, Duperchy E, Chang BY, Sukbuntherng J, Montoya JG, Styles L, Clow F, James D, Dubberke ER, Wilcox M. Okhuysen PC, et al. Among authors: louie t. Clin Infect Dis. 2024 Jun 14;78(6):1462-1472. doi: 10.1093/cid/ciad792. Clin Infect Dis. 2024. PMID: 38305378 Free PMC article. Clinical Trial.
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.
Khanna S, Assi M, Lee C, Yoho D, Louie T, Knapple W, Aguilar H, Garcia-Diaz J, Wang GP, Berry SM, Marion J, Su X, Braun T, Bancke L, Feuerstadt P. Khanna S, et al. Among authors: louie t. Drugs. 2022 Oct;82(15):1527-1538. doi: 10.1007/s40265-022-01797-x. Epub 2022 Oct 26. Drugs. 2022. PMID: 36287379 Free PMC article. Clinical Trial.
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.
Sims MD, Khanna S, Feuerstadt P, Louie TJ, Kelly CR, Huang ES, Hohmann EL, Wang EEL, Oneto C, Cohen SH, Berenson CS, Korman L, Lee C, Lashner B, Kraft CS, Ramesh M, Silverman M, Pardi DS, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L; ECOSPOR IV Investigators. Sims MD, et al. JAMA Netw Open. 2023 Feb 1;6(2):e2255758. doi: 10.1001/jamanetworkopen.2022.55758. JAMA Netw Open. 2023. PMID: 36780159 Free PMC article. Clinical Trial.
Redefining Clostridioides difficile infection antibiotic response and clinical outcomes.
Gonzales-Luna AJ, Skinner AM, Alonso CD, Bouza E, Cornely OA, de Meij TGJ, Drew RJ, Garey KW, Gerding DN, Johnson S, Kahn SA, Kato H, Kelly CP, Kelly CR, Kociolek LK, Kuijper EJ, Louie T, Riley TV, Sandora TJ, Vehreschild MJGT, Wilcox MH, Dubberke ER; EXPAND Cdiff group. Gonzales-Luna AJ, et al. Among authors: louie t. Lancet Infect Dis. 2023 Jul;23(7):e259-e265. doi: 10.1016/S1473-3099(23)00047-6. Epub 2023 Apr 14. Lancet Infect Dis. 2023. PMID: 37062301 Review.
Safety of fecal microbiota, live-jslm (REBYOTA™) in individuals with recurrent Clostridioides difficile infection: data from five prospective clinical trials.
Lee C, Louie T, Bancke L, Guthmueller B, Harvey A, Feuerstadt P, Khanna S, Orenstein R, Dubberke ER. Lee C, et al. Among authors: louie t. Therap Adv Gastroenterol. 2023 Jun 12;16:17562848231174277. doi: 10.1177/17562848231174277. eCollection 2023. Therap Adv Gastroenterol. 2023. PMID: 37333464 Free PMC article.
Prevalence of Comorbid Factors in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Randomized Trial of an Oral Microbiota-Based Therapeutic.
Berenson CS, Lashner B, Korman LY, Hohmann E, Deshpande A, Louie TJ, Sims M, Pardi D, Kraft CS, Wang EEL, Cohen SH, Feuerstadt P, Oneto C, Misra B, Pullman J, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Lee CH. Berenson CS, et al. Clin Infect Dis. 2023 Nov 30;77(11):1504-1510. doi: 10.1093/cid/ciad448. Clin Infect Dis. 2023. PMID: 37539715 Free PMC article. Clinical Trial.
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.
Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Kraft CS, et al. Among authors: louie tj. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28. Infect Dis Ther. 2024. PMID: 38941068 Free PMC article.
Correction to: Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.
Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Kraft CS, et al. Among authors: louie tj. Infect Dis Ther. 2024 Oct;13(10):2209-2210. doi: 10.1007/s40121-024-01036-8. Infect Dis Ther. 2024. PMID: 39212853 Free PMC article. No abstract available.
Correction to: 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.
Khanna S, Assi M, Lee C, Yoho D, Louie T, Knapple W, Aguilar H, Garcia-Diaz J, Wang GP, Berry SM, Marion J, Su X, Braun T, Bancke L, Feuerstadt P. Khanna S, et al. Among authors: louie t. Drugs. 2022 Oct;82(15):1539. doi: 10.1007/s40265-022-01805-0. Drugs. 2022. PMID: 36342618 Free PMC article. No abstract available.
240 results