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Erick Duan MD FRCPC Presented at the CCCTG Halifax, NS, June 2016

Clostridium difficile infection (CDI) in the ICU and Clostridium difficile outcomes in the PROSPECT Main Trial. Erick Duan MD FRCPC Presented at the CCCTG Halifax, NS, June 2016. Burden of C. difficile. Most common nosocomial cause of diarrhea

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Erick Duan MD FRCPC Presented at the CCCTG Halifax, NS, June 2016

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  1. Clostridium difficile infection (CDI)in the ICU and Clostridium difficile outcomes in the PROSPECT Main Trial Erick Duan MD FRCPC Presented at the CCCTG Halifax, NS, June 2016

  2. Burden of C. difficile Most common nosocomial cause of diarrhea More common nosocomial infection than MRSA In 2011 (US surveillance data): • 453,000 cases of CDI • 29,000 CDI associated deaths • Increased health care costof $1.5 billion USD Canadian point prevalence study: In 2002: 0.8% of all admissions In 2009: 1.2% of all admissions Leffler NEJM 2015 Taylor Antimicrob Res Inf Cont 2016

  3. And it’s getting worse Since 2002: more common more severe more refractory to treatment more recurrent infection Emergence of hypervirulent strain: 027/BI/NAP1 15-20x toxin production, production of binary toxin Outbreak in Sherbrooke, PQ (2002) Increased attributable mortality: 17% Increased rate of colectomy: 23% Pepin CMAJ 2005

  4. Clostridiumdifficle in the ICU Recurrent CDI Patients Exposures/Interventions Outcomes pre-ICU ICU renal failure shock colectomy length of stay Prevention of CDI Treatment of CDI ICU-acquired CDI ICU pts Hospital pts colonization with CD Mortality Morbidity ICU patientswith CDI Diagnosis of CDI Hospital pts with CDI severe, complicated or fulminant CDI pre-ICU CDI Treatment of CDI Recurrence Recurrent CDI Incidence Prevalence Risk Factors Prognostic Factors Outbreaks Attributable Morbidity and Mortality Attributable Cost

  5. Burden of C. difficile in ICU • Prevalence of ICU-acquired CDI varies greatly • 80 835 pts in 22 studies • Pooled estimate: prevalence of 2% (95%CI 1-2%) Karanika et al Open Forum Infectious Diseases 2016

  6. Burden of C. difficile in ICU Hospital mortality • With limitations, there is some signal that ICU acquired C. difficile infectionincreases hospital mortality and hospital LOS • Also,increases ICU LOSwithno difference in ICU mortality 32% 24% 95%CI 26-39% 14-36% Hospital LOS 50 vs 30 days Karanika et al Open Forum Infectious Diseases 2016

  7. Studies of C. difficile in ICU • Largely retrospective studies • Low event rate • Variable definitions of C. difficile infection • Severity unknown (and criteria never validated) • Complications poorly and inconsistently reported • Treatment poorly described

  8. What’s coming down the pipeline for CDI?

  9. What’s coming down the pipeline for CDI? • Fecal microbiota transplantation • Antibiotics: • fidaxomicin, teicoplanin, tigecycline • surtomycin, cadazolid • IVIG • Monoclonal antibodies • Vaccine

  10. What’s coming down the pipeline for CDI? • Fecal microbiota transplantation • Antibiotics: • fidaxomicin, teicoplanin, tigecycline • surtomycin, cadazolid • IVIG • Monoclonal antibodies • Vaccine

  11. Fecal microbiota transplantation • 89% cure rate in observational studies(273 CDI patients) • no adverse effects reported • compared to • 18% treatment failures with metronidazole • 60% chance of recurrence after 2 prior episodes Kassam Am J Gastroenterol 2013

  12. The trouble with fecal microbiota transplantation • typically stool donors are family members • stool collected within 6 hours of transplant • stool screening process is extensive, and not standardized • reported but not well studied in critically ill patients • concern about delaying surgical intervention in critically ill patients

  13. Frozen as good as fresh JAMA 2014 JAMA 2016 • 232 patients with recurrent CDI • Cure rates: • 83.5% frozen • 85.1% fresh

  14. Coming sometime to an ICU near you???

  15. Back to

  16. C. difficile data collection and outcome adjudication in PROSPECT

  17. Studies of C. difficile in ICU • largely retrospective studies • low event rate • highly variable definitions of C. difficile infection • severity unknown (and criteria never validated) • complications poorly and inconsistently reported • treatment poorly described

  18. C. difficile Data collection • CRF

  19. C. difficile data collection

  20. C. difficile Adjudication independent blind adjudication consensus on CDI and CDI related outcomes ED randomly allocated to a pair of adjudicators consensus DJC patients with possible CDI JD consensus JJ

  21. C. difficile Adjudication in PROSPECT

  22. C. difficile outcomes in PROSPECT Strengths: • duplicate adjudication • standard definition of CDI (Public Health Ontario) • application of multiple severity criteria • systematic collection of complications + treatments • rich patient baseline and daily data Limitations: • event rate is likely to be low • results in a selected RCT population

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