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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.
An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.
Kauf TL, McKinnon P, Corey GR, Bedolla J, Riska PF, Sims M, Jauregui-Peredo L, Friedman B, Hoehns JD, Mercier RC, Garcia-Diaz J, Brenneman SK, Ng D, Lodise T. Kauf TL, et al. BMC Infect Dis. 2015 Nov 7;15:503. doi: 10.1186/s12879-015-1261-9. BMC Infect Dis. 2015. PMID: 26547411 Free PMC article. Clinical Trial.
Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial.
Holland TL, Raad I, Boucher HW, Anderson DJ, Cosgrove SE, Aycock PS, Baddley JW, Chaftari AM, Chow SC, Chu VH, Carugati M, Cook P, Corey GR, Crowley AL, Daly J, Gu J, Hachem R, Horton J, Jenkins TC, Levine D, Miro JM, Pericas JM, Riska P, Rubin Z, Rupp ME, Schrank J Jr, Sims M, Wray D, Zervos M, Fowler VG Jr; Staphylococcal Bacteremia Investigators. Holland TL, et al. JAMA. 2018 Sep 25;320(12):1249-1258. doi: 10.1001/jama.2018.13155. JAMA. 2018. PMID: 30264119 Free PMC article. Clinical Trial.
Pharmacokinetic and Pharmacodynamic Profiling of Minocycline for Injection following a Single Infusion in Critically Ill Adults in a Phase IV Open-Label Multicenter Study (ACUMIN).
Lodise TP, Van Wart S, Sund ZM, Bressler AM, Khan A, Makley AT, Hamad Y, Salata RA, Silveira FP, Sims MD, Kabchi BA, Saad MA, Brown C, Oler RE Jr, Fowler V Jr, Wunderink RG. Lodise TP, et al. Among authors: sims md. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e01809-20. doi: 10.1128/AAC.01809-20. Print 2021 Feb 17. Antimicrob Agents Chemother. 2021. PMID: 33168615 Free PMC article. Clinical Trial.
SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection.
Feuerstadt P, Louie TJ, Lashner B, Wang EEL, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, Korman LY, Ford CB, Litcofsky KD, Lombardo MJ, Wortman JR, Wu H, Auniņš JG, McChalicher CWJ, Winkler JA, McGovern BH, Trucksis M, Henn MR, von Moltke L. Feuerstadt P, et al. N Engl J Med. 2022 Jan 20;386(3):220-229. doi: 10.1056/NEJMoa2106516. N Engl J Med. 2022. PMID: 35045228 Clinical Trial.
SER-109: An Oral Investigational Microbiome Therapeutic for Patients with Recurrent Clostridioides difficile Infection (rCDI).
Khanna S, Sims M, Louie TJ, Fischer M, LaPlante K, Allegretti J, Hasson BR, Fonte AT, McChalicher C, Ege DS, Bryant JA, Straub TJ, Ford CB, Henn MR, Wang EEL, von Moltke L, Wilcox MH. Khanna S, et al. Antibiotics (Basel). 2022 Sep 10;11(9):1234. doi: 10.3390/antibiotics11091234. Antibiotics (Basel). 2022. PMID: 36140013 Free PMC article. Review.
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. 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. 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.
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