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Vs VANCOMYCIN 125 Mg PO QID X10 DAYS PER PROTOCOL ANALYSIS P=NS CLOSTRIDIUM DIFFICILE UPDATE: A JOINT VENTURE AMERICAN COLLEGE OF OSTEOPATHIC INTERNISTS CLINICAL CHALLENGES IN INPATIENT CARE MATTHEW BECHTOLD MD, FACP, FASGE, FACG, AGAF DIVISION OF GASTROENTEROLOGY UNIVERSITY OF MISSOURI – COLUMBIA MARCH 25, 2017 DISCLOSURE AMERICAN COLLEGE OF OSTEOPATHIC INTERNISTS NATIONAL MEETING Nestle Nutrition Institute Speaker & Consultant I will not discuss off label use or investigational use in my presentation Matthew Bechtold MD [email protected] QUESTIONS What is the burden of This is a crappy C. difficile? topic What are the C. It’s a dirty job but difficile treatment someone has to do it recommendations? How do we treat This should be severe C. difficile? stimulating C. DIFFICILE BACKGROUND ANAEROBIC GRAM + BACILLUS SPORE-FORMING TOXIN-PRODUCING FIRST DESCRIBED IN 1935 PATHOGENIC ROLE DESCRIBED IN 1970’s SPORE FORM VEGETATIVE FORM OUTSIDE COLON INSIDE COLON RESISTENT TO HEAT, ACID, TOXIN-PRODUCING ANTIBIOTICS SUSCEPTIBLE TO ANTIBIOTICS Hall IC, et al. Am J Dis Child 1935 Bartlett JG. Ann Intern Med 2006 Bartlett JG, et al. Gastroenterology 1978 C. DIFFICILE BACKGROUND ANTIBIOTIC THERAPY DISRUPTION OF COLONIC MICROFLORA C. DIFFICILE EXPOSURE AND COLONIZATION RELEASE OF TOXIN A (ENTEROTOXIN) & TOXIN B (CYTOTOXIN) MUCOSAL INJURY & INFLAMMATION LaMont JT, et al. UptoDate 2014 C. DIFFICILE BACKGROUND J-STRAIN 1989-1992 RESISTENT TO CLINDAMYCIN NAP1/BI/027 STRAIN NORTH AMERICAN PULSED- 2003-2006 FIELD TYPE 1 RESTRICTION ENZYME MORE SEVERE, REFRACTORY, RELAPSE ANALYSIS TYPE BI PCR RIBOTYPE 027 INCREASED TOXIN PRODUCTION MAY BE DUE TO FLUOROQUINOLONES 078 STRAIN SINCE 2005 SIMILAR TO 027 YOUNGER Miller M, et al. Clin Infect Dis 2010 COMMUNITY-ASSOCIATED Pepcin J, et al. Clin Infect Dis 2005 He M, et al. Nat Genet 2013 Goorhuis A, et al. Clin Infect Dis 2008 CLOSTRIDIUM DIFFICILE BURDEN EPIDEMIOLOGY GASTROENTERITIS-ASSOCIATED DEATHS IN UNITED STATES 1999 – 2007 Cause ICD-10 Code(s) Total No. of Deaths (%) Mean Annual No. of Deaths Rate per 1 000 000a Cause unspecifiedb 44 444 (49.4) 5556 19.1 Presumed infectious A09 1163 (1.3) 145 0.5 Presumed noninfective K52.9 39 310 (43.7) 4914 16.9 Other or unspecified viral A08.3-A08.5 1325 (1.5) 166 0.6 Acute or unspecified vascularc K55.0, K55.9 2815 (3.1) 352 1.2 Cause specifiedb 45 596 (50.6) 5700 19.6 Viral A08.0-A08.2 85 (0.1) 11 0.04 Clostridium difficile A04.7 43 517 (48.3) 5440 18.7 A00.0-A04.6, A04.8- Other bacterial 1665 (1.8) 208 0.7 A05.9 Parasitic A06.0-A07.9 348 (0.4) 44 0.1 Total 90 040 (100) 11 255 38.8 Hall AJ, et al. Clin Infect Dis 2012 EPIDEMIOLOGY UNITED STATES 1997 – 2012 Ivarsson ME, et al. Drug Discov Today - Epub 2014 EPIDEMIOLOGY INCIDENCE (PER 100,000 POPULATION) OF CDAD SHERBROOKE, QUEBEC 1991–2003 Pepin J, et al. CMAJ 2004 EPIDEMIOLOGY ANTIBIOTIC RECEIVED ≤ 2 MONTHS BEFORE CDAD SHERBROOKE, QUEBEC 1991–2003 Pepin J, et al. CMAJ 2004 EPIDEMIOLOGY PROSPECTIVE COHORT IN NETHERLANDS 13 HOSPITALS (n=1,366) 2006-2009 2.5-FOLD INCREASED 30-DAY MORTALITY RATE (HAZARD RATIO 2.5; 95% CI: 1.4-4.3) ADJUSTED FOR AGE, SEX, AND UNDERLYING DISEASES Hensgens MP, et al. Clin Infect Dis 2013 EPIDEMIOLOGY PROSPECTIVE COHORT IN NETHERLANDS 13 HOSPITALS (n=1,366) 2006-2009 Deaths <30 d <3 mo <1 y Total N = 1350 Stratification % (n = 177) % (n = 319) % (n = 497) Age group, y ≤9 58 0.0 1.7 6.9 10–19 40 2.5 7.5 15.0 20–29 33 6.1 9.1 12.1 30–39 52 1.9 3.8 15.4 40–49 90 10.0 14.4 28.9 50–59 191 12.0 18.8 28.3 60–69 252 11.9 23.0 34..5 70–79 351 14.5 29.9 45.6 80–89 244 21.3 34.8 51.2 ≥90 39 20.5 33.3 59.0 PCR ribotype 014 111 10.8 20.7 32.4 078 76 14.5 23.7 38.2 001 57 15.8 22.8 33.3 027 55 21.8 32.7 40.0 Other 387 10.1 20.2 34.9 No type result 664 14.2 25.5 38.6 Hensgens MP, et al. Clin Infect Dis 2013 EPIDEMIOLOGY NOSOCOMIAL HO‐HCFA, Healthcare facility–onset, healthcare facility–associated CDI CO-HCFA, Community‐onset, healthcare facility–associated disease CA-CDI, Community‐associated CDI COMMUNITY- ASSOCIATED Cohen SH, et al. Infect Control Hosp Epidemiol 2010 NOSOCOMIAL CDAD RETROSPECTIVE STUDY IN UNITED STATES NATIONAL HOSPITAL DISCHARGE SURVEY BY CDC 1996-2003 70 61 60 50 CDAD RATE 40 31 PER 100,000 30 20 10 0 1996 2003 McDonald LC, et al. Emerg Infect Dis 2006 NOSOCOMIAL CDAD RETROSPECTIVE STUDY IN UNITED STATES NATIONAL HOSPITAL DISCHARGE SURVEY BY CDC 1996-2003 McDonald LC, et al. Emerg Infect Dis 2006 NOSOCOMIAL CDAD PROSPECTIVE COHORT AT BARNES-JEWISH HOSPITAL JUNE 20104.5 – OCTOBER 2011 259 ASYMPTOMATIC PATIENTS 4 PROSPECTIVE COHORT STOOL OR SWAB SPECIMEN NORTHWESTERN 3.5 RECTAL SWAB CULTURE n=810 3 250 2.5 % 204 CDAD 2 1.5 200 1 0.5 150 0 # OF PATIENTS NEWLY EXPOSED 100 COLONIZED 40 50 15 0 NO CD COLONONIZED WITH COLONONIZED WITH TOX CD NON-TOX CD Alasmari F, et al. Clin Infect Dis 2014 Shim JK, et al. Lancet 1998 COMMUNITY CDAD POPULATION-BASED STUDY IN OLMSTED COUNTY MINNESOTA ROCHESTER EPIDEMIOLOGY PROJECT n=385 1991-2005 14.9 16 14 12 10 CDAD RATE PER 100,000 PERSON- 8 YEARS 6 2.8 4 2 0 1991-1993 2003-2005 Khanna S. et al. Am J Gastroenterol 2012 COMMUNITY CDAD POPULATION-BASED STUDY IN OLMSTED COUNTY MINNESOTA ROCHESTER EPIDEMIOLOGY PROJECT n=385 1991-2005 100 90 80 COMMUNITY-ACQUIRED 70 HOSPITAL-ACQUIRED 60 % 50 40 30 20 10 0 AGE FEMALE ANTIBIOTIC ACID CANCER SEVERE EXPOSURE SUPPRESSION INFECTION USE Khanna S. et al. Am J Gastroenterol 2012 WHY? SICKER PATIENTS (IMMUNOSUPPRESSION, COMORBIDITIES, ELDERLY) CHANGING ANTIBIOTIC PRESCRIBING CHANGING INFECTION CONTROL PRACTICES NOVEL RISK FACTORS (PPIs) NEW STRAINS (ANTIBIOTIC RESISTANCE, NOVEL TOXIN PROFILE) LaMont JT, et al. UptoDate 2014 CLOSTRIDIUM DIFFICILE CLINICAL ASPECTS CLINICAL SYMPTOMS DIARRHEA UP TO 10-15/DAY LOWER ABDOMINAL PAIN LEUKOCYTOSIS PROSPECTIVE COHORT IN UPENN 30 n=3,005 JANUARY 2013 – OCTOBER 2013 25 20 % CDAD 15 10 n=286 n=1,063 n=1,656 5 0 5 6 7 Wanahita A, et al. Clin Infect Dis 2002 Heaton KW, et al. Gut 1992 BRISTOL STOOL SCALE Caroff DA, et al. J Clin Microbiol 2014 RISK FACTORS ANTIBIOTIC USE HOSPITALIZATION ADVANCED AGE SEVERE ILLNESS ACID SUPPRESSION ENTERAL FEEDING GASTROINTESINAL SURGERY OBESITY CHEMOTHERAPY Loo VG, et al. NEJM 2011 ANTIBIOTICS & CDAD FREQUENT FLUOROQUINOLONES CLINDAMYCIN PENICILLINS (BROAD-SPECTRUM) CEPHALOSPORINS (BROAD-SPECTRUM) OCCASIONAL MACROLIDES TRIMETHOPRIM SULFONAMIDES RARE AMINOGLYCOSIDES TETRACYCLINE CHLORAMPHENICOL METRONIDAZOLE VANCOMYCIN Loo VG, et al. NEJM 2011 LaMont JT, et al. UptoDate 2014 CLINICAL SPECTRUM NONE ASYMPTOMATIC NONE CARRIER CDAD WITH COLITIS SEVERITY DIARRHEA PSEUDOMEMBRANOUS COLITIS SEVERE FULMINANT SEVERE COLITIS Wanahita A, et al. Clin Infect Dis 2002 ASYMPTOMATIC CARRIER 50 50 45 40 35 % 30 CARRIERS 25 20 20 15 10 5 0 HOSPITALIZED LONG-TERM FACILITY McFarland LV, et al. NEJM 1989 Riggs MM, et al. Clin Infect Dis 2007 CDAD WITH COLITIS DIARRHEA UP TO 10-15/DAY LOWER ABDOMINAL PAIN LEUKOCYTOSIS (mean ~15,000) LaMont JT, et al. UptoDate 2014 CDAD WITH COLITIS PROSPECTIVE COHORT IN HOUSTON TEXAS UNEXPLAINED LEUKOCYTOSIS (WBC ≥ 15,000/mm3) VS HOSPITALIZED PATIENTS WITHOUT LEUKOCYTOSIS STOOL BY EIA FOR C. DIFFICILE TOXIN n=60 VS 26 58 60 50 40 % C. DIFFICILE TOXIN + 30 20 12 10 0 LEUKOCYTOSIS CONTROLS Wanahita A, et al. Am J Med 2003 PSEUDOMEMBRANOUS COLITIS Courtesy of James B McGee MD Courtesy of James B McGee MD RELEASE OF TOXIN-INDUCED SERUM PROTEINS, SHALLOW CYSTOSKELETON MUCUS, ULCERATIONS DISRUPTION INFLAMMATORY CELLS Riegler M, et al. J Clin Invest 1995 LaMont JT, et al. UptoDate 2014 PSEUDOMEMBRANOUS COLITIS 3 TYPES TYPE 1 MILDER INFLAMMATION IN SUPERFICIAL EPITHELIUM CRYPT ABSCESSES OCCASIONAL TYPE 2 SEVERE DISRUPTION OF GLANDS MUCIN SECRETION INFLAMMATION IN BASAL LAMINA TYPE 3 INTENSE NECROSIS FULL THICKNESS INFLAMMATION CONFLUENT PSEUDOMEMBRANES Price AB, et al. J Clin Pathol 1977 FULMINANT COLITIS SEVERE PAIN +/- DIARRHEA FEVER HYPOVOLUMEMIA SEVERE LEUKOCYTOSIS (40,000) Courtesy of J Thomas LaMont MD TOXIC MEGACOLON COLONIC DILATION (>7 cm) + SYSTEMIC TOXICITY LaMont JT, et al. UptoDate 2014 CLINICAL SPECTRUM SEVERITY CRITERIA MILD-TO-MODERATE DIARRHEA + ANY ADDITIONAL SIGNS OR SYMPTOMS DISEASE NOT MEETING SEVERE OR COMPLICATED CRITERIA SEVERE SERUM ALBUMIN < 3 g/dl + ONE OF FOLLOWING: DISEASE - WBC ≥ 15,000 cells/mm3 - ABDOMINAL TENDERNESS SEVERE & COMPLICATED ANY OF THE FOLLOWING ATTRIBUTABLE TO CDAD: DISEASE - ADMISSION TO ICU FOR CDAD - HYPOTENSION ± VASOPRESSORS - FEVER ≥ 38.5oC - ILEUS OR SIGNIFICANT ABDOMINAL DISTENTION - MENTAL STATUS CHANGES - WBC ≥ 35,000 cells/mm3 OR < 2,000 cells/mm3 - SERUM LACTATE > 2.2 mmol/l - END ORGAN FAILURE (VENTILATOR, RENAL FAILURE, ETC) RECURRENT RECURRENT CDAD ≤ 8 WEEKS OF COMPLETION OF DISEASE THERAPY Surawicz CM, et al. Am J Gastroenterol 2013 DIAGNOSIS DIARRHEA AND STOOL TEST + FOR C. ENDOSCOPIC/HISTOLOGIC DIFFICILE TOXINS OR OR PSEUDOMEMBRANOUS TOXIGENIC C. DIFFICILE COLITIS Kelly CP, et al. NEJM 1994 Crobach MJ, et al. Clin Microbiol Infect 2009 STOOL STUDIES POLYMERASE CHAIN REACTION ENZYME IMMUNOASSAY FOR C. DIFFICILE GLUTAMATE DEHYDROGENASE ENZYME IMMUNOASSAY FOR C. DIFFICILE TOXINS A & B CELL CULTURE CYTOTOXICITY ASSAY SELECTIVE ANAEROBIC CULTURE Cohen SH, et al. Infect Control Hosp Epidemiol 2010 Kufelnicka AM, et al. Clin Infect Dis 2011 STOOL STUDIES STOOL STUDY SENSITIVITY/SPECIFITY EXTRAS PCR 87% / 97% ~ 1 HOUR EXPENSIVE EIA FOR GDH 75-90% / >90% GDH IS AN ESSENTIAL ENZYME CANNOT DIFFENTIATE TOXIC FROM NON-TOXIC STRAINS HIGH FALSE + EIA FOR TOXINS 60-85% / 95-100% HIGH FALSE – NEED 100-1000 pg OF TOXIN CELL CULTURE 95-100% / 99% STOOL ON CULTURED CELLS TOXIN AFFECTS FIBROBLASTS CYTOTOXICITY NOT WIDELY AVAILABLE ASSAY SLOW, ~ 2 DAYS EXPENSIVE NOT STANDARDIZED SELECTIVE 96% / 100% VERY SLOW LABOR INTENSIVE ANAEROBIC CULTURE Luo RF, et al.
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