The Treatment of Clostridium difficile Infection
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1 The Treatment of Clostridium difficile Infection Andrew E. Simor, MD, FRCPC, FACP Sunnybrook Health Sciences Centre University of Toronto, Toronto, ON
2 Disclosures I have received grants, and served as a consultant on Advisory Boards for: BD GeneOhm Diagnostics Merck Frosst Canada Ltd Optimer Pharmaceuticals Canada
3 Objectives to review evidence-based clinical practice guidelines for the management Clostridium difficile infection to consider novel approaches for the treatment of patients with C. difficile infection
4 Clostridium difficile implicated in 20%-30% of antibiotic-associated diarrhea major cause of nosocomial infectious diarrhea disease caused by production of toxin A and toxin B McFarland, NEJM 1989; Bartlett, Clin Infect Dis 1992
5 C. difficile Toxins Toxin A enterotoxin, causing intestinal mucosal injury and fluid secretion Toxin B cytotoxin, disrupts intestinal cell tight junctions
6 C. difficile Pathogenesis Acquisition of toxigenic C. difficile followed by disruption of normal bowel flora (eg. with use of antibiotics) Toxin Ab present No toxin Ab asymptomatic C. difficile- C. difficile colonization associated diarrhea
7 C. difficile Complications acute abdomen, peritonitis, toxic megacolon, colon perforation recurrent infection
8 Recurrent C. difficile occurs in 20-30%; may be relapse or re-infection a recurrence is associated with a higher risk of repeated recurrences often associated with concurrent or repeat antibiotic therapy Pépin, Clin Infect Dis 2006; Kelly, N Engl J Med 2008
9 C. difficile Diagnosis CDI should be suspected in any hospitalized patient with diarrhea who has received antibiotics in the previous 2 months (fever and leukocytosis are often present).
10 The Latest in C. difficile Diagnostics Bomers, BMJ 2012
11 Test C. difficile Diagnosis Sensitivity (%) Specificity (%) Culture > Cytotoxin assay >97 EIA toxin assay GDH (common Ag) PCR for toxin B >90 >96 Peterson, Ann Intern Med 2009; Eastwood, J Clin Microbiol 2009
12 Cohen, Infect Control Hosp Epidemiol 2010
13 CDI Treatment Guidelines General Principles Discontinue inciting antibiotic(s) as soon as possible (A-II) If severe CDI is suspected, begin empiric treatment as soon as possible (C-III) Avoid anti-peristaltic agents (C-III) SHEA/IDSA Guidelines, Infect Control Hosp Epidemiol 2010
14 Concurrent Antibiotics and Response To Treatment for C. difficile Infection Mullane, Clin Infect Dis 2011
15 Vancomycin or Metronidazole?
16 Vancomycin vs Metronidazole (early studies) Study Antibiotic No. patients Initial cure (%) Recurrence (%) 1 Vanco Metro Vanco Metro Teasley, Lancet 1983; 2 Wenisch, Clin Infect Dis 1996
17 Efficacy of Vancomycin and Metronidazole for Treatment of C. difficile Infection Zar, Clin Infect Dis 2007 Tolevamer studies (Louie, ICAAC, Washington, 2007; Bouza, ESCMID, Barcelona, Spain, 2008)
18 C. difficile Treatment Response Rates Zar, Clin Infect Dis 2007
19 Criteria for Severe C. difficile Infection Pseudomembranous colitis Treatment in an ICU Any two of: Age > 60 yrs Temp > 38.3 C WBC > 15,000 Albumin < 2.5 mg/dl Zar, Clin Infect Dis 2007
20 C.difficile Treatment Treatment guidelines stratified: - first episode or recurrence - disease severity SHEA/IDSA Guidelines, Infect Control Hosp Epidemiol 2010
21 C. difficile Infection (CDI) Mild-Moderate CDI Severe CDI Definitions WBC 15,000/mm 3 or rising creatinine > 50% higher than before Severe complicated CDI criteria as above plus hypotension, ileus, perforation, toxic megacolon Cohen, Infect Control Hosp Epidemiol 2010
22 CDI Treatment Guidelines First Episode CDI 1 st episode, mild-moderate 1 st episode, severe Treatment metronidazole 500 mg PO tid X days vancomycin 125 mg PO qid X days Cohen, Infect Control Hosp Epidemiol 2010
23 CDI Treatment Guidelines First Episode CDI Treatment 1 st episode, severe, complicated vancomycin 500 mg PO qid + IV metronidazole ± vancomycin rectal instillation Cohen, Infect Control Hosp Epidemiol 2010
24 Bass, J Hosp Infect 2013 In severe CDI, addition of metronidazole to vancomycin had no benefit.
25 Severe, Complicated CDI Surgery (colectomy) may be life-saving Consider colectomy if toxic megacolon, colonic perforation, septic shock Serum lactate >5 mmol/l, postoperative mortality > 75% Lamontagne, Ann Surg 2007
26 Surgical Management of Severe CDI Diverting loop ileostomy with colonic lavage may be an alternative to colectomy Neal, Ann Surg 2011
27 CDI Treatment Guidelines Recurrent Disease CDI Treatment 1 st recurrence same as for initial episode 2 nd recurrence vancomycin, pulsed/tapered Cohen, Infect Control Hosp Epidemiol 2010
28 Treatment of Recurrent CDI Tapered vancomycin: 500 mg qid X 14 days and then slowly tapered over 6-12 wks Pulsed vancomycin: 500 mg qid X 14 days and then 500 mg very 2-3 days X 6-12 wks (± subsequent taper) McFarland, Am J Gastroenterol 2002
29 Other Antimicrobial Agents for the Treatment of CDI teicoplanin, fusidic acid, bacitracin have all had equal efficacy to Vanco/Metronidazole in small RCTs (equal response to treatment and recurrence rates) McFarland, J Med Microbiol 2005
30 for the treatment of C. difficile infection?
31 New Treatment Strategies for C. difficile new drugs immune modulation non-toxigenic C. difficile restoration of fecal microbiota
32 Fidaxomicin (Dificid TM ) macrocyclic antibiotic inhibits RNA synthesis inhibits C. difficile sporulation and toxin production minimal absorption; fecal concentrations >MIC 90 (0.125 µg/ml) usual dose: 200 mg. BID
33 Cornely, Lancet Infect Dis 2012 Louie, New Engl J Med 2011
34 Fidaxomicin vs Vancomycin for C. difficile Infection 2 large international double-blind RCTs fidaxomicin and vancomycin had similar cure rates (88% vs 86%) lower recurrence rates with fidaxomicin (15% vs 25%, esp. non-nap-1 strains; P=0.005) Louie, N Engl J Med 2011; Cornely, Lancet Infect Dis 2012
35 Louie, N Engl J Med 2011
36 Drug Fidaxomicin vs Vancomycin: Sustained Clinical Response Response rates (%) End of 25 days after treatment end of treatment Vancomycin Fidaxomicin * * p<0.001 Louie, N Engl J Med 2011; Cornely, Lancet Infect Dis 2012; Johnson, Antimicrob Agents Chemother 2012
37 Response to Therapy and Recurrence Rates in Patients with Epidemic (BI) C. difficile Outcome Vancomycin (n=363) Fidaxomicin (n=356) REA Group BI (NAP1) 127 (35) 120 (34) Other 236 (65) 236 (66) Cure rate BI (NAP1) 109 (86) 105 (88) Other 220 (93)* 225 (95)* Recurrence rate (%) Overall 99 (25) 51 (13)* BI (NAP1) 30 (31) 21 (23) Other 69 (25) 30 (13)* Petrella, Clin Infect Dis 2012 * P < 0.001
38 Fidaxomicin vs Vancomycin for C. difficile Infection subset analysis suggests fidaxomicin more effective than vancomycin in patients taking concurrent antibiotics (Mullane, Clin Infect Dis 2011) subset analysis suggests in patients with a 1 st recurrence, fidaxomicin had similar clinical response as vancomcyin, but was superior in preventing another recurrence within 28 days (Cornely, Clin Infect Dis 2012)
39 Why Might Fidaxomicin Reduce Rates of Recurrent CDI? fidaxomicin preserves normal intestinal bacterial flora 1 fidaxomicin inhibits C. difficile sporulation 2 1 Louie, Clin Infect Dis 2012; 2 Babakhani, Clin Infect Dis 2012
40 Other New Drugs for the Treatment of CDI Rifamixin: in a series of 8 patients with recurrent CDI, Vanco followed by rifamixin effective (Johnson, Clin Infect Dis 2007) Nitazoxanide: in a small RCT, equivalent to metronidazole (Musher, Clin Infect Dis 2006) Tigecycline: effective in a small series of patients with severe refractory CDI (Herpers, Clin Infect Dis 2009)
41 Immune Modulation as Treatment for C. difficile Infection IVIG Anti-toxin monoclonal antibodies Vaccine (toxoid)
42 IVIG for Treatment of C. difficile Infection anecdotal reports, case series in patients with severe or recurrent CDI some studies show benefit, but others do not Wilcox, J Antimicrob Chemother 2004; McPherson, Dis Colon Rectum 2006; Juang, Am J Infect Control 2007
43 Addition of human monoclonal antibodies against toxin A & toxin B to standard therapy reduced risk of recurrence (7% vs 25%; P<0.001) in phase II clinical trial Lowy, N Engl J Med 2010
44 Other Approaches for C. difficile Treatment CamSA (bile salt analog, inhibits C. difficile sporulation) Non-toxigenic C. difficile Fecal transplant ( the only time you should take crap from a spouse )
45 Summary Treatment of CDI with metronidazole or vancomycin should be based on disease severity. Fidaxomicin has equivalent response rate to vancomycin, but is associated with fewer recurrent infections. Other treatment strategies are being investigated.
46 The End
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