Ridinilazole for the treatment of Clostridioides difficile infection

References

• Hall IC, O’Toole E. Intestinal flora in new-born infants with a description of a new pathogenic anaerobe. Bacillus Difficilis Am J Dis Child. 1935;49(2):390–402.
   Google Scholar
• McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996–2003. Emerg Infect Dis. 2006;12(3):409–415.
   PubMed Web of Science ®Google Scholar
• Khanna S, Pardi DS, Aronson SL, et al. The epidemiology of community-acquired Clostridium difficile infection: a population-based study. Am J Gastroenterol. 2012;107:89–95.
   PubMed Web of Science ®Google Scholar
• Miller BA, Chen LF, Sexton DJ, et al. Comparison of the burdens of hospital-onset, healthcare facility-associated Clostridium difficile infection and of healthcare-associated infection due to methicillin-resistant staphYlococcus aureus in community hospitals. Infec Control Hosp Epidemiol. 2011;32(4):387–390.
   PubMed Web of Science ®Google Scholar
• Magill SS, O’Leary E, Janelle SJ, et al. Changes in prevalence of health care-associated infections in U.S. hospitals. N Engl J Med. 2018;379(18):1732–1744.
   PubMed Web of Science ®Google Scholar
• Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825–834.
   PubMed Web of Science ®Google Scholar
• Hall AJ, Curns AT, McDonald LC, et al. The roles of Clostridium difficile and Norovirus among gastroenteritis-associated deaths in the United States, 1999–2007. Clin Infect Dis. 2012;55(2):216–223.
   PubMed Web of Science ®Google Scholar
• Dubberke ER, Olsen MA. Burden of Clostridium difficile on the healthcare system. Clin Infect Dis. 2012;55(S2):S88–S92.
   PubMedGoogle Scholar
• Johnson S, Samore MH, Farrow KA, et al. Epidemics of diarrhea caused by a clindamycin-resistant strain of Clostridium difficile in four hospitals. N Engl J Med. 1999;341(22):1645–1651.
   PubMed Web of Science ®Google Scholar
• McDonald LC, Killgore GE, Thompson A, et al. An epidemic, toxin gene-variant strain of Clostridium difficile. N Engl J Med. 2005;353(23):2433–2441.
   PubMed Web of Science ®Google Scholar
• Loo VG, Poirier L, Miller MA, et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005;353(23):2442–2449.
   PubMed Web of Science ®Google Scholar
• Warny M, Pepin J, Fang A, et al. Toxin production by an emerging strain of Clostridium difficile associated with outbreaks of severe disease in North America and Europe. Lancet. 2005;366:1079–1084.
   PubMed Web of Science ®Google Scholar
• Voth DE, Ballard JD. Clostridium difficile toxins: mechanism of action and role in disease. Clin Microbiol Rev. 2005;18(2):247–263.
   PubMed Web of Science ®Google Scholar
• Vedantam G, Clark A, Chu M, et al. Clostridium difficile infection: toxins and non-toxin virulence factors, and their contributions to disease establishment and host response. Gut Microbes. 2012;3(2):121–134.
   PubMed Web of Science ®Google Scholar
• Mulligan ME, Rolfe RD, Finegold SM, et al. Contamination of a hospital environment by Clostridium difficile. Curr Microbiol. 1979;3(3):173–175.
   Web of Science ®Google Scholar
• Kim KH, Fekety R, Batts DH, et al. Isolation of Clostridium difficile from the environment and contacts of patients with antibiotic-associated colitis. J Infect Dis. 1981;143(1):42–50.
   PubMed Web of Science ®Google Scholar
• Saif NA, Brazier JS. The distribution of Clostridium difficile in the environment of South Wales. J Med Microbiol. 1996;45:133–137.
   PubMed Web of Science ®Google Scholar
• Alam MJ, Walk ST, Endres BT, et al. Community environmental contamination of toxigenic Clostridium difficile. Open Forum Infect Dis. 2017. Published online 2017 Feb 10. DOI:10.1093/ofid/ofx018.
   Web of Science ®Google Scholar
• Louie T, Nord CE, Talbot GH, et al. Multicenter, double-blind, randomized, phase 2 study evaluating the novel antibiotic cadazolid in patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2015;59(10):6266–6273.
   PubMed Web of Science ®Google Scholar
• Lee CH, Patino H, Stevens C, et al. Surotomycin versus vancomycin for Clostridium difficile infection: phase 2, randomized, controlled, double-blind, non-inferiority, multicentre trial. J Antimicrob Chemother. 2016;71(10):2964–2971.
   PubMed Web of Science ®Google Scholar
• Boix V, Redorak RN, Mullane KM, et al. Primary outcomes from a phase 3, randomized, double-blind, active-controlled trial of surotomycin in subjects with clostridium difficile infection. Open Forum Infect Dis. Published online 2017 Jan 19 . 2017. DOI:10.1093/ofid/ofw275
   PubMed Web of Science ®Google Scholar
• Daley P, Louie T, Lutz JE, et al. Surotomycin versus vancomycin in adults with Clostridium difficile infection: primary clinical outcomes from the second pivotal, randomized, double-blind, phase 3 trial. J Antimicrob Chemother. 2017;72(12):3462–3470.
   PubMed Web of Science ®Google Scholar
• McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1–e48.
   PubMed Web of Science ®Google Scholar
• Zar FA, Bakkanagari SR, Moorthi KM, et al. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007;45(3):302–307.
   PubMed Web of Science ®Google Scholar
• Johnson S, Louie TJ, Gerding DN, et al. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014;59(3):345–354.
   PubMed Web of Science ®Google Scholar
• Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(Suppl. 6):21–27.
   PubMed Web of Science ®Google Scholar
• Beinortas T, Burr NE, Wilcox MH, et al. Comparative efficacy of treatments for Clostridium difficile infection: a systematic review and network meta-analysis. Lancet Infect Dis. 2018;18:1035–1044.
   PubMed Web of Science ®Google Scholar
• Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422–431.
   PubMed Web of Science ®Google Scholar
• Cornely OA, Crook DW, Esposito R, et al. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012;12:281–289.
   PubMed Web of Science ®Google Scholar
• Mann J, Taylor PW, Dorgan CR, et al. The discovery of a novel antibiotic for the treatment of Clostridium difficile infections: a story of an effective academic-industrial partnership. Med Chem Commun. 2015;6:1420–1426.
   Google Scholar
• Basseres E, Endres BT, Khaleduzzaman M, et al. Impact on toxin production and cell morphology in Clostridium difficile by ridinilazole (SMT19969), a novel treatment for C. difficile infection. J Antimicrob Chemother. 2016;71:1245–1251.
   PubMed Web of Science ®Google Scholar
• Goldstein EJ, Citron DM, Tyrrell KL, et al. Comparative in vitro activities of SMT19969, a new antimicrobial agent, against Clostridium difficile and 350 Gram-positive and Gram-negative aerobic and anaerobic intestinal flora isolates. Antimicrob Agents Chemother. 2013;57(10):4872–4876.
   PubMed Web of Science ®Google Scholar
• Goldstein EJ, Citron DM, Tyrrell KL. Comparative in vitro activities of SMT19969, a new antimicrobial agent, against 162 strains from 35 less frequently recovered intestinal Clostridium species: implications for Clostridium difficile recurrence. Antimicrob Agents Chemother. 2014;58(2):1187–1191.
   PubMed Web of Science ®Google Scholar
• Corbett D, Wise A, Birchall S, et al. In vitro susceptibility of Clostridium difficile to SMT19969 and comparators, as well as the killing kinetics and post-antibiotic effects of SMT19969 and comparators against C. difficile. J Antimicrob Chemother. 2015;70:1751–1756.
   PubMed Web of Science ®Google Scholar
• Freeman J, Vernon J, Vickers RJ, et al. Susceptibility of Clostridium difficile isolates of varying antimicrobial resistance phenotypes to SMT19969 and 11 comparators. Antimicrob Agents Chemother. 2016;60(1):689–692.
   PubMed Web of Science ®Google Scholar
• Louie TJ, Emery J, Krulicki W, et al. OPT-80 eliminates Clostridium difficile and is sparing of Bacteroides species during treatment of C. difficile infection. Antimicrob Agents Chemother. 2009;53(1):261–263.
   PubMed Web of Science ®Google Scholar
• Tannock GW, Munro K, Taylor C, et al. A new macrocyclic antibiotic, fidaxomicin (OPT-80), causes less alteration to the bowel microbiota of Clostridium difficile-infected patients than does vancomycin. Microbiology. 2010;156:3354–3359.
   PubMed Web of Science ®Google Scholar
• Snydman DR, McDermott LA, Thorpe CM, et al. Antimicrobial susceptibility and ribotypes of Clostridium difficile isolates from a phase 2 clinical trial of ridinilazole (SMT19969) and vancomycin. J Antimicrob Chemother. 2018;73:2078–2084.
   PubMed Web of Science ®Google Scholar
• Ackermann G, Loffler B, Adler D, et al. In vitro activity of OPT-80 against Clostridium difficile. Antimicrob Agents Chemother. 2004;48(6):2280–2282.
   PubMed Web of Science ®Google Scholar
• Citron DM, Bacakhani F, Goldstein EJ, et al. Typing and susceptibility of bacterial isolates from the fidaxomicin (OPT-80) phase II study for C. difficile infection. Anaerobe. 2009;15(6):234–236.
   PubMed Web of Science ®Google Scholar
• Vickers RJ, Tillotson GS, Nathan R, et al. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Lancet Infect Dis. 2017;17:735–744.
   PubMed Web of Science ®Google Scholar
• Baines SD, Crowther GS, Freeman J, et al. SMT19969 as a treatment for Clostridium difficile infection: an assessment of antimicrobial activity using conventional susceptibility testing and an in vitro gut model. J Antimicrob Chemother. 2015;70:182–189.
   PubMed Web of Science ®Google Scholar
• Vickers RJ, Robinson N, Best E, et al. A randomized phase 1 study to investigate safety, pharmacokinetics and impact on gut microbiota following single and multiple oral doses in healthy male participants of SMT19969, a novel agent for Clostridium difficile infections. BMC Infect Dis. 2015;15:91–100.
   PubMed Web of Science ®Google Scholar
• Thorpe CM, Kane AV, Chang J, et al. Enhanced preservation of the human intestinal microbiota by ridinilazole, a novel Clostridium difficile-targeting antibacterial, compared to vancomycin. PLoS ONE. Published online 2018 Aug 2. 2018. DOI:10.1371/journalpone.0199810
   Web of Science ®Google Scholar
• Weiss W, Pulse M, Vickers RJ. In vivo assessment of SMT19969 in a hamster model of Clostridium difficile infection. Antimicrob Agents Chemother. 2014;58(10):5714–5718.
   PubMed Web of Science ®Google Scholar
• Sattar A, Thommes P, Lloyd P, et al. SMT19969 for Clostridium difficile infection (CDI): in vivo efficacy compared with fidaxomicin and vancomycin in the hamster model of CDI. J Antimicrob Chemother. 2015;70:1757–1762.
   PubMed Web of Science ®Google Scholar
• Louie TJ, Miller M, Donskey C, et al. Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2009;53(1):223–228.
   PubMed Web of Science ®Google Scholar
• Babakhani F, Bouillaut L, Sears P, et al. Fidaxomicin inhibits toxin production in Clostridium difficile. J Antimicrob Chemother. 2013;68:515–522.
   PubMed Web of Science ®Google Scholar
• Koo HL, Van JN, Zhao M, et al. Real-time polymerase chain reaction detection of asymptomatic Clostridium difficile colonization and rising C. difficile-associated disease rates. Infect Control Hosp Epidemiol. 2014;35(6):667–673.
   PubMed Web of Science ®Google Scholar
• Burdet C, Sayah-Jeanne S, Nguyen TT, et al. Antibiotic-induced dysbiosis predicts mortality in an animal model of Clostridium difficile infection. Antimicrob Agents Chemother. 2018;62(10):e00925–18.
   PubMed Web of Science ®Google Scholar
• Garey KW, Ghantoji SS, Shah DN, et al. A randomized, double-blind, placebo-controlled pilot study to assess the ability of rifaximin to prevent recurrent diarrhoea in patients with Clostridium difficile infection. J Antimicrob Chemother. 2011;66(12):2850–2855.
   PubMed Web of Science ®Google Scholar
• Shah DN, Aitken SL, Barragan LF, et al. Economic burden of primary compared with recurrent Clostridium difficile infection in hospitalized patients: a prospective cohort study. J Hosp Infect. 2016;93(3):286–289.
   PubMed Web of Science ®Google Scholar
• Garey KW, Aitken SL, Gschwind L, et al. Development and validation of a Clostridium difficile health-related quality-of-life questionnaire. J Clin Gastroenterol. 2016;50(8):631–637.
   PubMed Web of Science ®Google Scholar