4. European Centre for Disease Prevention and Control/European Medicines Agency (ECDC/EMEA). Joint technical report The bacterial challenge: time to react. Stockholm: ECDC / EMEA; 2009. Available from: http://ecdc.europa.eu/en/publications/Pu... (last accessed April 2017).
5. Kuijper EJ, et al. ESCMID study group for Clostridium difficile. Emergence of Clostridium difficile associated disease in North America and Europe. Clin Microbiol Infect. 2006;12:2-18.
6. DIFICLIR Summary of Product Characteristics (SmPC) for European Union, 2016.
7. Guery B, et al. Randomised, controlled, open-label study comparing the efficacy of extended-pulsed fidaxomicin (EPFX) with vancomycin therapy for sustained clinical cure of Clostridium difficile infection in an older population: the EXTEND study. NCT02254967 study information. Available from: https://clinicaltrials.gov/ct2/show/NCT0... (last accessed April 2017).
8. Chilton CH, et al. Successful treatment of simulated Clostridium difficile infection in a human gut model by fidaxomicin first line and after vancomycin or metronidazole failure. J Antimicrob Chemother. 2014;69(2):451-62.
9. Watt M, et al. Cost-effectiveness of extended-pulsed fidaxomicin (EPFX) versus standard vancomycin (SV) in older patients with Clostridium difficile infection in England. Abstract presented at ECCMID 2017.
10. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent epidemiologic findings and advances in therapy. Pharmacotherapy. 2007;27:1029-39.1.
11. Sunenshine R, McDonald L. Clostridium difficile-associated disease: new challenges from an established pathogen. Cleve Clin J Med. 2006;73:187-97.
12. European Centre for Disease Prevention and Control (ECDC). Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals 2011-2012. Stockholm, 2013. Available from: http://ecdc.europa.eu/en/publications/Pu... (last accessed April 2017).
13. Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.
14. Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect Dis. 2013;56:1108-16.
15. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009;15:1067-79.
16. Johnson S, et al. Vancomycin, Metronidazole, or Tolevamer for Clostridium difficile Infection: Results From Two Multinational, Randomized, Controlled Trials. Clin Infect Dis. 2014;59(3):345-54.
17. Lowy I, et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010;362;3:197-205.
18. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422-31.
19. Mullane KM, Gorbach S. Fidaxomicin: first-in-class macrocyclic antibiotic. Expert Rev. Anti Infect. Ther. 2011;9(7):767-777.
20. Babakhani F, et al. Killing kinetics of fidaxomicin and its major metabolite, OP 1118, against Clostridium difficile. J Med Microbiol. 2011;60:1213-7.
21. Finegold SM, et al. In vitro activities of OPT-80 and comparator drugs against intestinal bacteria. Antimicrobial agents and chemotherapy. 2004;48:4898-902.
22. Tannock GW, 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.
23. Louie TJ, et al. OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection. AAC. 2009;53:261-263.
24. Weiss K, Allgren RL, Sellers S. Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections. Clin Infect Dis. 2012;55(S2) :S110-15.
25. Debast SB, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): update of the treatment guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect. 2014:20(s2):1-26.
April 2017
AI/17/0001/CB
CONTACT: For further information please contact: Josie Fisher, Ruder Finn,jfisher@ruderfinn.co.uk, Tel: +44(0) 20-7438-3068; Astellas Pharma EMEAPress Office, Tel: +44(0)7919-302-926