Fidaxomicin: A new option for the treatment of clostridium difficile infection

Journal of Antimicrobial Chemotherapy

Volumn 67, Issue 12, 2012, Pages 2788-2792

  Johnson, Alan P ^a   Wilcox, Mark H ^b  

^a PUBLIC HEALTH ENGLAND   (United Kingdom)

^b LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

Antibiotic associated diarrhoea; Macrocyclic antibiotic; OPT 80

Indexed keywords

FIDAXOMICIN; VANCOMYCIN;

ADVERSE OUTCOME; ANTIBACTERIAL ACTIVITY; BACTERIAL STRAIN; CHILL; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM DIFFICILE INFECTION; DOSE RESPONSE; DRUG ABSORPTION; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG SCREENING; DRUG STRUCTURE; FEVER; GASTROINTESTINAL DISEASE; HUMAN; IN VITRO STUDY; INFECTION; MINIMUM INHIBITORY CONCENTRATION; NONHUMAN; PAIN; PATIENT SAFETY; RECURRENT DISEASE; REVIEW; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

AMINOGLYCOSIDES; ANTI-BACTERIAL AGENTS; CLINICAL TRIALS AS TOPIC; CLOSTRIDIUM INFECTIONS; DIARRHEA; EUROPE; HUMANS; RECURRENCE; TREATMENT OUTCOME; UNITED STATES;

EID: 84869430977     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dks302     Document Type: Review

References (36)

1. Freeman J, Bauer MP, Baines SD et al. The changing epidemiology of Clostridium difficile infections. Clin Microbiol Rev 2010; 23: 529-49.
2. HPA. Results from the mandatory surveillance of Clostridium difficile infection. CDI reports by Primary Care Organization (PCO). http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1254510678961 (24 May 2012, date last accessed).
3. Kyne L, Hamel MB, Polavaram R et al. Health care costs and mortality associated with nosocomial diarrhoea due to Clostridium difficile. Clin Infect Dis 2002; 34: 346-53.
4. O'Brien JA, Lahue BJ, Caro JJ et al. The emerging infectious challenge of Clostridium difficile-associated disease in Massachusetts hospitals: clinical and economic consequences. Infect Control Hosp Epidemiol 2007; 28: 1219-27.
5. Dubberke ER, Wertheimer AI. Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol 2009; 30: 57-66.
6. Wiegand PN, Nathwani D, Wilcox MH et al. Clinical and economic burden of Clostridium difficile infection in Europe: a systematic review of healthcare-facility-acquired infection. J Hosp Infect 2012; 81: 1-14.
7. Zar FA, Bakkanagari SR, Moorthi KM et al. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhoea, stratified by disease severity. Clin Infect Dis 2007; 45: 302-7.
8. Johnson S. Recurrent Clostridium difficile infection: a review of risk factors, treatments, and outcomes. J Infect 2009; 58: 403-10.
9. Fekety R. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol 1997; 92: 739-50.
10. Baines SD, O'Connor R, Freeman J et al. Emergence of reduced susceptibility to metronidazole in Clostridium difficile. J Antimicrob Chemother 2008; 62: 1046-52.
11. Kuijper EJ, Wilcox MH. Decreased effectiveness of metronidazole for the treatment of Clostridium difficile infection? Clin Infect Dis 2008; 47: 63-5.
12. Johnson AP. OPT-80, a narrow-spectrum macrocyclic antibiotic. Current Opin Invest Drugs 2007; 8: 168-73.
13. Optimer Pharmaceuticals Inc. Anti-Infective Drugs Advisory Committee Meeting Briefing Document. DificidTM (fidaxomicin tablets) for the treatment of Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhoea (CDAD), and for reducing the risk of recurrence when used for treatment of initial CDI. NDA 201699, April 5, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM249354.pdf (17 May, date last accessed).
14. Ackermann G, Loffler B, Adler D et al. In vitro activity of OPT-80 against Clostridium difficile. Antimicrob Agents Chemother 2004; 48: 2280-82.
15. Credito KL, Appelbaum PC. Activity of OPT-80, a novel macrocycle, compared with those of eight other agents against selected anaerobic species. Antimicrob Agents Chemother 2004; 48: 4430-34.
16. Finegold SM, Molitoris D, Vaisanen ML et al. In vitro activities of OPT-80 and comparator drugs against intestinal bacteria. Antimicrob Agents Chemother 2004; 48: 4898-902.
17. Hecht DW, Galang MA, Sambol SP et al. In vitro activities of 15 antimicrobial agents against 110 toxigenic Clostridium difficile clinical isolates collected from 1983 to 2004. Antimicrob Agents Chemother 2007; 51: 2716-19.
18. Karlowski JA, Laing NM, Zhanel GG. In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile. Antimicrob Agents Chemother 2008; 52: 4163-65.
19. Citron DM, Babakhani F, Goldstein EJC et al. Typing and susceptibility of bacterial isolates from the fidaxomicin (OPT-80) phase II study for C. difficile infection. Anaerobe 2009; 15: 234-36.
20. Goldstein E, Citron D, Sears P et al. Comparative fidaxomicin susceptibilities of isolates collected at baseline, failure and recurrence from patients in a phase III trial of Clostridium difficile infection (CDI). In: Abstracts of the Forty-ninth Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, 2009. Abstract L1-1641. American Society for Microbiology, Washington, DC, USA.
21. Babakhani F, Robert N, Shangle S et al. Antimicrobial activity and post-antibiotic effect (PAE) of OPT-80, a new macrocyclic compound, against Clostridium difficile. In: Abstracts of the Forty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2004. Abstract E-2048. American Society for Microbiology, Washington, DC, USA.
22. 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: 3354-59.
23. 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: 261-3.
24. Swanson RN, Hardy DJ, Shipkowitz NL et al. In vitro and in vivo evaluation of tiacumicins B and C against Clostridium difficile. Antimicrob Agents Chemother 1991; 35: 1108-11.
25. Okumu F, Walsh RB, Sears P et al. Safety and pharmacokinetics of OPT-80, a novel antibiotic for treatment of Clostridium difficile associated diarrhoea (CDAD). In: Abstracts of the Forty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2004. Abstract F-726. American Society for Microbiology, Washington, DC, USA.
26. Shue YK, Sears PS, Shangle S et al. Safety, tolerance, and pharmacokinetic studies of OPT-80 in healthy volunteers following single and multiple oral doses. Antimicrob Agents Chemother 2008; 52: 1391-95.
27. Louie T, 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: 223-28.
28. Louie TJ, Miller MA, Mullane KM et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011; 364: 422-31.
29. 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: 281-9.
30. Hubert B, Loo VG, Bourgault A-M et al. A portrait of the geographic dissemination of the Clostridium difficile North American pulsed-field type 1 strain and the epidemiology of C. difficile-associated disease in Quebec. Clin Infect Dis 2007; 44: 238-44.
31. Petrella LA, Sambol SP, Cheknis A et al. Decreased cure and increased recurrence rates for Clostridium difficile infection caused by the epidemic C. difficile B1 strain. Clin Infect Dis 2012; 55: 351-7.
32. Mullane KM, Miller MA, Weiss K et al. Efficacy of fidaxomicin versus vancomycin as therapy for Clostridium difficile infection in individuals taking concomitant antibiotics for other concurrent infections. Clin Infect Dis 2011; 53: 440-7. Erratum in: Clin Infect Dis 2011; 53: 1312.
33. Mullane KM, Gorbach S. Fidaxomicin: first-in-class macrocyclic antibiotic. Exp Rev Anti Infect Ther 2011; 9: 767-77.
34. Goldstein EJC, Citron DM, Sears P et al. Comparative susceptibilities to fidaxomicin (OPT-80) of isolates collected at baseline, recurrence, and failure from patients in two phase III trials of fidaxomicin against Clostridium difficile infection. Antimicrob Agents Chemother 2011; 55: 5194-99.
35. Hu MY, Katchar K, Kyne L et al. Prospective derivation and validation of a clinical prediction rule for recurrent Clostridium difficile infection. Gastroenterology 2009; 136: 1206-14.
36. Eyre DW, Wyllie D, Dingle KE et al. Predictors of recurrent Clostridium difficile infection: implications for initial management. In: Abstracts of the Forty-ninth Conference of the Infectious Diseases Society of America, Boston, MA, 2011. Abstract 352. Infectious Diseases Society of America, Arlington, VA, USA.