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What’s new in Clostridioides difficile infection diagnostics and prevention

What’s new in Clostridioides difficile infection diagnostics and prevention. March 9 th , 2019 Brooke K. Decker, MD, CIC Director, Antimicrobial Stewardship Director, Infection Prevention VA Pittsburgh Healthcare System. Learning objectives.

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What’s new in Clostridioides difficile infection diagnostics and prevention

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  1. What’s new in Clostridioides difficile infection diagnostics and prevention March 9th, 2019 Brooke K. Decker, MD, CIC Director, Antimicrobial Stewardship Director, Infection Prevention VA Pittsburgh Healthcare System

  2. Learning objectives • Describe Clostridioides difficile diagnostics and guideline recommended testing strategy • Discuss C. diff prevention approaches

  3. Talk outline • Testing algorithm(s) • Primary prevention • Secondary prevention Clostridioides difficile [klos–TRID–e–OY-deesdif–uh–SEEL] Clostridioides difficile Infection (CDI) • 500,000 cases/year in US • 15,000 directly attributable deaths CDC 2015

  4. How to test for CDI • Only test patients with symptoms • Unexplained, ≥3 diarrheal stools: Bristol scale 6 or 7 only -- “unformed” • +/- fever • Abdominal pain • Anorexia • Nausea • ~7% pts colonized! Bristol Stool Scale Lewis & Heaton, Scand. J. Gastroenterol 1997 Galdys J Clin Microbiol 2014

  5. CDI risk - intestinal dysbiosis • Antibiotic exposure (necessary or unnecessary) • fluoroquinolones, third/fourth generation cephalosporins, clindamycin, carbapenems • Gastrointestinal surgery/manipulation • Healthcare exposure • Immunocompromise • Advanced age • Proton pump inhibitors, H2-blockers McDonald Clinical Infectious Diseases 2018

  6. Available tests • Enzyme immunoassay (EIA) for toxin • EIA for glutamate dehydrogenase (GDH) • Nucleic acid amplification (NAAT) • Algorithm recommended (EIA + NAAT or NAAT + EIA?) McDonald Clinical Infectious Diseases 2018

  7. A patient presenting with positive NAT testing for C. difficile should prompt: • Immediate guideline-concordant rx for CDI • Immediate contact isolation • Re-evaluation of hospital testing strategy • A phone call to your Antimicrobial Stewardship coordinator • Further clinical investigation

  8. Test comparison Moon PLoS ONE 2016

  9. Algorithm strategy • PCR as part of 2-step algorithm had significantly improved PPV: 93-100% Caulfield Diagn Microbiol Infect Dis. 2018

  10. Peng Emerg Microbes Infect. 2018

  11. Alternative to 2-step: Stool QC • Educate clinicians to only send stool on patients with symptoms and clinical picture consistent with CDI and no recent use of laxative • Empower laboratory personnel to reject non-liquid specimens • This may be as effective in improving PPV as a multistep algorithm McDonald Clinical Infectious Diseases 2018

  12. Algorithm strategy • Toxin EIA is not sensitive (false negative) • NAAT is very sensitive (false positive) • First-step NAAT + confirmatory toxin EIA • Sensitivity + potential reduction in unnecessarily reported cases • NAAT+/Tox- cases may be heterogenous regarding infected status • Your CEO wants a 2-step NAAT-EIA strategy (reduced reporting of HO-CDI) Planche Lancet Infect Dis 2013 Zou Eur J Clin Microbiol Infect Dis. 2018

  13. Primary Prevention • Antibiotic Stewardship • Baur Lancet Infect Dis 2017 • Contact isolation • Environmental Cleaning • Healthcare worker hand hygiene • Universal Screening? • Probiotics?

  14. Contact isolation • Private, single room, dedicated toilet • Gloves and gowns for HCW • Isolate pending results of testing • Isolation duration?? • At least 48 hours • 5 days? • Hospitalization duration? McDonald Clinical Infectious Diseases 2018

  15. Potentially infectious C. difficile may remain in the environment for: • 1-2 days • 1-2 weeks • 1-2 months • Until the next bleach clean/UV light cycle

  16. Sites were cleaned daily and after each collection (continued shedding) Sethi Infect Control Hosp Epidemiol. 2010

  17. Environmental Cleaning • Floors/surfaces • RME

  18. Floors • Historically controversial in CDI cleaning • Spore-active cleaners hard on flooring • It’s probably a real risk

  19. Solutions • Enhanced room cleaning methodology (targeted vs. universal) • Hydrogen peroxide • Periodic bleach cleaning • UV light disinfection Marra Infect Control Hosp Epidemiol 2018 Anderson Lancet 2017 Anderson Lancet Infect Dis 2018

  20. Environmental Cleaning - RME • Reusable medical equipment (RME) • It’s everything • Who cleans it • What do they clean it with • How often

  21. Solutions • Find out who cleans RME • Prepare for the answer to be no one • Ensure RME cleaning is assigned, trained, and validated • Consider a universal periodic bleach clean day – “Bleach clean Friday”

  22. Universal Screening • Melzer – 3.4% hospital admissions positive by PCR • HO-CDI 4.6/10k for non-colonized pts • HO-CDI 76.6/10k for colonized pts • Longtin – 4.8% positive on admission, all isolated on detection. • HO-CDI 6.9/10k pre-intervention • HO-CDI 3/10k during intervention Melzer ClinMicrobiol Infect. 2019 Longtin JAMA Intern Med. 2016

  23. Probiotics or no biotics • Lactobacilli and bifidobacterial (PLACIDE) study • No evidence of prevention of antibiotic or C. diff associated diarrhea • RBX2660 (suspension of donor stool administered by enema) • 2 doses superior to placebo in RCT, 1 dose not superior over placebo Allen Lancet. 2013 DubberkeClin Infect Dis. 2018

  24. Secondary Prevention • Your patient with a history of CDI needs broad-spectrum antibiotics again!

  25. Oral Vancomycin Prophylaxis (OVP) • Retrospective study -- history of CDI treated with OVP (vanc 250 bid, 125 bid) • OVP group recurrence 4.2% • Control group 26.6% • Long term treatment with 125 mg OVP may be effective in preventing relapse • OVP 125 mg po daily or bid effective 2ndary PPX • Oral vanc 125 mg po bid for allo-SCT pts – 0% CDI in ppx’d, 20% in non-ppx’d group Van HiseClin Infect Dis. 2016 Zhang BMC Infect Dis 2019 Brown Ann Pharmacother 2019 Ganetsky Clin Infect Dis. 2018

  26. Fidaxomcyin vs. placebo: DEFLECT-1 • CDI (primary) prevention for Allo-SCT • CDI from start of study to 30 days post-treatment similar: • Treated: 28.6% • Placebo: 30.8%

  27. Pending RCT Studies • Randomized OVP - NCT03200093, NCT03466502 • Randomized to Rifaximin - NCT01670149

  28. News you can use: • Know how your lab is testing (and add your grains of salt as needed) • Wash your hands and bleach your stethoscope (and other RME) • Stay tuned for much-needed additional research on secondary prophylaxis

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