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Emergence of Antimicrobial Resistance Ebbing Lautenbach, MD, MPH Assistant Professor of Medicine and Epidemiology Associate Hospital Epidemiologist, Hospital of the University of Pennsylvania Center for Clinical Epidemiology & Biostatistics University of Pennsylvania School of Medicine PENN Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance • Clinical Impact on resistance • Strategies to curb further emergence of resistance Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance • Clinical Impact on resistance • Strategies to curb further emergence of resistance Emergence of Gram + Resistance: US 100 1980 to 1999 Percent of Pathogens Resistant to Antibiotics 90 80 70 MRSE 60 MRSA 50 40 NPSP 30 VRE 20 10 0 1975 VISA VTSP LRSA VRSA 1980 1985 1990 1995 1997 Adapted from Thronsberry C. et al. 38th ICAAC, 1998; San Diego, Calif. Abstract E22 MMWR Morb Mortal Wkly Rep. 1997;46(27):624-636 2000 2002 Emergence of Gram - Resistance 25 % organisms resistant 20 FQ-R P. aeruginosa 15 10 Ceftaz-R K. pneumoniae FQ-R E. coli 5 0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 New Agents with Expanded in Vitro Gram-Positive Activity [Glycopeptides – Balhimycin – HelvecardinA – HelvecardinB – MDL62208 – MDL62211 – MDL62476 (A40926) – MDL63042 – MDL63166 – MDL63246 – LY333328 [Quinolones – Trovafloxacin – Clinafloxacin – Gatifloxacin – Moxifloxacin – DU 6859 – ABT 719 [Lipoglycopeptides – Ramoplanin [Lipopeptides – Daptomycin [Everninomycins – SCH27899 [Streptogramins – Quinupristin/Dalfopristin [Ketolides – RU64004 – RU66647 [Oxazolidinones – U100592 – Linezolid [Glycylcyclines – DMG-DMDOT – DMG-MINO New Agents with Expanded Gram Negative Activity Trends in Development of New Antibacterials Total # New Antibacterial Agents 18 *R2 = 0.99 16 14 12 10 8 6 4 2 0 1983-1987 1988-1992 1993-1997 1998-2002 *p = 0.007 by linear regression New antibacterial agent new molecular entity (NME) with antimicrobial properties, administered for systemic infection; topical agents, immunomodulators excluded Edwards J, ICAAC, 2003 Potential Reasons for Pharmaceutical Company Shifts Away From Anti-infective Development •Shift in demographics of population to elderly •Need for treatment of chronic diseases •Antibiotics become auto-obsolete •Thought leaders advocating conservative use •Increasing standards for efficacy and safety evaluation •Increasingly complex patients in clinical trials •Significantly increased costs in clinical trials •Attractive to develop agents used for life of patients Edwards J, ICAAC, 2003 Pharmaceutical R&D : 15 largest by revenue Table 5. Anti-bacterial NMEs vs. Others Indication #NME Lifestyle Drugs Anxiety/Depression Bladder Hyperactivity GERD/Irritable Bowel Syndrome Obesity Impotence Smoking Cessation Insomnia Migraine Restless Leg Syndrome 42 12 8 7 4 4 2 2 1 1 Osteoporosis 8 Dementia 7 Anti-bacterials 5 Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance • Clinical Impact on resistance • Strategies to curb further emergence of resistance Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance – 2 examples • Fluoroquinolone resistance • Vancomycin-resistant enterococci • Clinical Impact on resistance • Strategies to curb further emergence of resistance Importance of FQ Resistance •One of the most commonly used antibiotic classes1,2 •Most common antibiotic used in nursing homes3 • • • • Broad spectrum Oral bioavailability Long half-life Well tolerated 1. Thomson, J Antimicrob Chemother, 1994 2. Lee, Am J Infect Control, 1998 3. Steinman, Ann Intern Med, 2003 Quinolones • DNA Gyrase –Supercoiling –4 subunits • 2 A subunits (gyrA gene) • 2 B subunits (gyrB gene) DNA gyrase (B subunit) • Topoisomerase IV –Acts in terminal stages of DNA replication –Separates newly replicated daughter strands –2 subunits • ParC (GrlA in S. aureus) • ParE (GrlB in S. aureus) Trends in FQ Resistance Surveillance study GN bacilli ICUs from 43 states 1994 – 2000 35,790 isolates Cipro susceptibility decreased from 86% to 76% No difference across: teaching vs non-teaching >500 beds vs < 500 beds Neuhauser MM, JAMA 2003;289:885 FQ Resistance vs FQ Use PA (r=0.976; p<0.001) GNB (r=0.891; p<0.001) Neuhauser MM, JAMA 2003;289:885 FQR-EC and FQ Use 7 100 90 6 E. coli (r = 0.79; p = 0.002) % FQ Resistance 5 70 60 4 50 3 40 30 2 DDD/1000 patient-days 80 20 1 10 0 0 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 Lautenbach, SHEA, 2002 FQR-EC and the Dow Jones IA 7 6 12000 E. coli (r=.96; p<.001) 10000 8000 4 6000 3 4000 2 2000 1 0 0 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 DJIA % FQ Resistance 5 Risk Factors for Nosocomial FQ Resistance in E. coli and K. pneumoniae • Case-control study (1/1/98 – 6/30/99) • Sites – Hospital of the Univ. of Penn (HUP) – Presbyterian Medical Center (PMC) • Subjects identified through Clinical Micro Lab at HUP • Study subjects – 123 cases (FQ-resistant) – 70 controls (FQ-susceptible) • Review of inpatient medical records Lautenbach, Arch Intern Med 2002;162:2469 Multivariable Model Variable Unadj OR Adj OR (95%CI) FQ Use 4.24 5.25 (1.81, 15.26) LTCF 4.71 3.65 (1.64, 8.15) Aminoglycoside Use 5.08 8.86 (1.71, 45.99) Age 1.03 (1.01, 1.06) Sex 1.83 2.11 (0.97, 4.56) Hospital 0.33 0.52 (0.24, 1.13) Organism (KP) 0.77 0.65 (0.27, 1.57) Lautenbach, Arch Intern Med 2002;162:2469 Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance – 2 examples • Fluoroquinolone resistance • Vancomycin-resistant enterococci • Clinical Impact on resistance • Strategies to curb further emergence of resistance Importance of Enterococci • 3rd most common hospital pathogen – 10-12% of all nosocomial infections • 3rd most common cause of BSI – 3-4 per 10,000 discharges • 1980s: incidence of enterococcal bacteremia in teaching hospitals increased up to 197% 1 1. NNIS, Am J Med 1991;91(suppl 3B):86S Emergence of VRE • First isolated in vitro in 1969 1 • Described clinically in 1988 2,3 • Mechanism of resistance – Alteration of cell wall precursors – Several resistance phenotypes • VanA and VanB most clinically significant 1. Toala, Am J Med Sci 1969;258:416 2. Leclercq, NEJM 1988;319:157 3. Uttley, Lancet 1988;1:57 Progression of Vancomycin Resistance: Enterococci Resistant isolates (%) 30 25 20 Non-ICU 15 ICU 10 5 0 1989 90 91 92 93 94 95 96 97 98 99* Martone WJ. Infect Control Hosp Epidemiol. 1998;19:539-545. NNIS Antimicrobial Resistance Surveillance Report. 1999. *through June 1999 (www.cdCgov/ncidod/hip/NNIS/AR_Surv1198.htm). Risk Factors: An Exhaustive (ing) List • • • • • • • • • • • Age Duration of hospitalization ICU admission Renal insufficiency Immunosuppression Neutropenia Hematologic malignancy Solid organ transplant Bone marrow transplant AIDS Prior Surgery • Antibiotics - General – Number / Duration • Antibiotics - Specific – Almost all implicated • Diarrhea / C. difficile • Central venous catheter • Urinary catheter • Prior Colonization • Exposure to VRE source – VRE-infected patient – Inanimate Object – Health Care Worker Risk factors for VRE (HUP) • Case control study (1/1/93 - 12/31/95); HUP • 260 cases enterococcal bacteremia – 72 VRE Risk factor Vancomycin use Renal insufficiency Neutropenia OR (95%CI) 3.0 (1.4,6.4) 4.4 (2.0,9.7) 6.3 (1.5,26.7) p value .005 <.001 .013 Lautenbach, Infect Control Hosp Epidemiol, 1999;20:318 VRE Risk Factors Author/Year Journal Population #VRE pts Cont grp Edmond ‘95 CID Morris ’95 Ann Int Med Shay ‘95 JID Papanicolaou ’96 CID Linden ‘96 CID Dahms ‘98 Arch Surg Lucas ‘98 CID Stosor ‘98 Arch Int Med Lautenbach ‘99 ICHE Bhavnani ’00 Diag Micro Inf Dis Oncology 11 SICU 20 Hosp-wide 46 Liver txp 32 Liver txp Inf Site MV Anal Risk Factors Onc pts BSI no SICU pts VSE Mult yes BSI yes Mult yes 54 OLT pts VSE BSI no Anaerobic agent use, VRE GI colonization Vanc use, Cipro use, APACHE, abx-days APACHE, Vanc use, Heme malignancy Surgical re-exploration, Prolonged ICU stay Length of stay Surgery 32 VSE Mult yes Hosp-wide 93 VSE BSI yes Hosp-wide 21 VSE BSI no Hosp-wide 72 VSE BSI yes Hosp-Wide 150 VSE BSI yes 3rd Gen Ceph use, Vanc use Length of stay, CVC, White race, Surgery Vanc use, Urine cath, Length of stay, AG use Abx-days, Renal insuff Vanc use, Neutropenia AIDS, Drug abuse, Vanc use, Liver Transplant Risk Factors: Modifiable Variables • • • • • • • • • • • Age Duration of hospitalization ICU admission Renal insufficiency Immunosuppression Neutropenia Hematologic malignancy Solid organ transplant Bone marrow transplant AIDS Prior Surgery • Antibiotics - General – Number / Duration • Antibiotics - Specific – Almost all implicated • Diarrhea / C. difficile • Central venous catheter • Urinary catheter • Prior Colonization • Exposure to VRE source – VRE-infected patient – Inanimate Object – Health Care Worker Exposure to VRE Source • To develop VRE infection, one must first be exposed to the organism • Extent of exposure is related to other risk factors: – Duration of hospitalization – ICU admission – Age – Greater severity of illness – Indwelling devices Sources of VRE Acquisition • VRE-infected patients • “Colonization pressure” 1 • Inanimate objects Gowns, Bed linens, Cabinets, ECG wires, Floors, etc. • Room contamination • > 50% of rooms may become contaminated • May remain viable up to several months • Healthcare workers? 1. Bonten, Arch Intern Med 1998;158:1127 Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance • Clinical impact on resistance • Strategies to curb further emergence of resistance Impact of Antimicrobial Resistance • Increased morbidity / mortality 1,2 • Increased cost – Estimated annual excess hospital costs in the United States = $100 million - $30 billion3 1. Patton, Med Clin North Am, 1991 2. Cohen, Science, 1992 3. Phelps, Med Care, 1989 Impact of Resistance on Antibiotic Use • Increased complexity of empiric antibiotic coverage • Greater empiric use of antibiotics • Increased use of broad spectrum antibiotics • Perpetuates the cycle of resistance Impact of FQ Resistance on Clinical Outcome • Retrospective cohort design • All patients with clinical E. coli or K. pneumoniae isolates – 123 patients with FQ-resistant isolate – 70 patients with FQ-susceptible isolate • January 1, 1998 - June 30, 1999 • Sites – Hospital of the Univ. of Penn (HUP) • 725-bed academic medical center – Presbyterian Medical Center (PMC) • 344-bed urban community hospital Lautenbach et al, SHEA, 2002 % Mortality Results: Mortality 10 9 8 7 6 5 4 3 2 1 0 P=0.05 8.1% 1.4% Infection-Related Mortality FQ-susceptible (n=70) FQ-Resistant (n=123) Lautenbach, SHEA, 2002 Multivariable Model: Risk Factors for Mortality Variable Unadj OR Adj OR (95%CI) P value FQ Resistance 6.61 8.83 (0.97, 80.59) 0.054 Bloodstream Involvement 4.87 4.89 (1.23, 19.42) 0.024 1.13 (1.01, 1.26) 0.033 4.30 (1.03, 17.94) 0.045 APACHE II Score ICU Location 4.34 Lautenbach, SHEA, 2002 % Patients Receiving Appropriate Therapy Time to Effective Therapy 80 70 FQ Resistant FQ Susceptible 60 50 40 30 20 10 0 Within 24 hours Within 48 hours Time after Culture Lautenbach et al, SHEA, 2002 Impact of VRE on Emergence of Other Resistance Patterns • Resistance transferable to S. aureus in vitro 1 • 8-month prospective study of S. aureus and VRE co-colonization in the GI tract 2 – Of 37 patients colonized with VRE, 23 (62%) had S. aureus recovered from stool • Of these, 20 (87%) had MRSA – 25% of stools with S. aureus contained >1,000,000 organisms/gram of stool 1. Noble WC, FEMS Microbiol Lett 1992 72:195 2. Ray AJ, Clin Infect Dis 2003 37:875 Glycopeptide Resistance in S. aureus VISA Isolates: PFGE Analysis Lane 1-S. Aureus Lane 2-MRSA Lane 3-VISA (pt#1) Lane 4-MRSA (pt#1) Lane 5-VISA (pt#2) Smith, NEJM 1999;340:493 VRSA - 2002 VanA + Chang S, N Engl J Med 2003;348:1342 Outline • Recent trends in emerging antibiotic resistance • Epidemiology of resistance • Clinical impact on resistance • Strategies to curb further emergence of resistance Prevention of Spread: VRE • How do findings relate to infection risk? • Only a minority of patients become colonized when cared for in a contaminated room 1 • Elucidation of mechanisms of VRE acquisition • Implement more effective infection control interventions • Enhanced surveillance • Patients infected or colonized with VRE have equal potential for transmission • Patient transfer between facilities 1. Bonten, Lancet 1996;348:1615 Antibiotic Use: Is There Room for Improvement? “The desire to ingest medicines is one of the principal features which distinguish man from the animals” Osler W. Aecquanimitas,1920 Implications: Addressing FQ Overuse / Misuse • On whom/Where are they being used? –Inpatient –Outpatient –Emergency Departments • Why/How are they being used? –Indications –Dose/duration How are FQs Used: Appropriateness in Inpatients None 1% First line 35% Alternative 59% Experimental 5% Ena, Diagn Microbiol Infect Dis 1998 Appropriateness of FQ Use: EDs • FQ Drug Use Evaluation (DUE) • Sites: 2 Academic Medical Center Emergency Departments (EDs) • Subjects: 100 patients seen in EDs, then discharged • Appropriateness (of indication) of therapy judged by existing institutional guidelines –www.med.upenn.edu/bugdrug –3 independent ID reviewers Lautenbach, Arch Intern Med 2003;163:601 Appropriateness of ED FQ Use 81% of courses inappropriate No Infection (n=27) 33% Other Agent First Line (n=43) 53% Insufficient Information (n=11) 14% Lautenbach, Arch Intern Med 2003;163:601 Appropriateness by Site of Infection 50 Appropriate Inappropriate 40 p=0.76 30 20 10 0 Ur l t t e a a c u a n o r r ti ss T h s i r l i T e T ta e/ i ft sp int s n e o o o e S R / tr N / G s n r i Ga Ea Sk ry a n i ry o t a O r e h t Lautenbach, Arch Intern Med 2003;163:601 Appropriateness of FQ Use: EDs • 19/100 (19%) patients received appropriate FQ therapy (judged by indication) –14 received both an incorrect dose & duration –4 received either an incorrect dose or duration –1 received the correct dose and duration • Variation of FQ use by ED –ED#1 (training program): 74% inappropriate –ED#2 (no training program): 86% inappropriate • OR (95%CI) = 0.39 (0.14, 1.09) Lautenbach, Arch Intern Med 2003;163:601 Potential Strategies • Guidelines • Antibiotic cycling • Antimicrobial optimization Potential Strategies • Guidelines • Antibiotic cycling • Antimicrobial optimization Awareness and Use of CAP Guidelines • Survey study of 621 physicians – ATS CAP guidelines / local CAP guidelines • 7 Pittsburgh area hospitals – 1 University – 3 community teaching – 3 community non-teaching • 345/621 (56%) responded – Generalists (79%) – ID (6%) – Pulmonologist (5%) Switzer GE, J Gen Intern Med 2003;18:816 Awareness and Use of CAP Guidelines Used guideline (20%) Not at all familiar (21%) n=345 Read guideline (30%) Have seen guideline (29%) Switzer GE, J Gen Intern Med 2003;18:816 Predictors of Use of ATS Guidelines Variable Adj OR (95%CI) Practicing as pulmonary or ID specialist 4.51 (1.71, 11.90) Spending more time in non-patient related activities 1.02 (1.00, 1.05) Higher “intellect” score* 2.18 (1.07, 4.40) * Goldberg Personality Scale Switzer GE, J Gen Intern Med 2003;18:816 Awareness and Use of CAP Guidelines • 6 of 7 study hospitals had local guidelines for CAP • 290 respondents from the 6 hospitals – 41% reported that no local guidelines existed – 30% of respondents reported they used the guideline more than half of the time in CAP therapy • 48 respondents from the hospital without a guideline, – 14% said it their hospital did have a guideline • Local CAP guideline use was associated with: – Practicing as a generalist: OR=0.10; 95%CI (0.01-0.89) – Positive attitude toward guidelines: OR=1.05 95%CI (0.99-1.11) Switzer GE, J Gen Intern Med 2003;18:816 Limitations of Guidelines • Discrepancies across guidelines • Lack of RCT data to support recommendations • Little regional/local susceptibility data • Poor correlation between in vitro resistance and clinical response • Failure to consider future emergence of resistance Luh JY, Arch Intern Med 2003;163:1617 Potential Strategies • Guidelines • Antibiotic cycling • Antimicrobial optimization Antibiotic Cycling • Periodic removal of certain agents / classes • Goals: – Prevention of VAP – Curb emergence of antibiotic resistance – Optimize empiric antibiotic selection • Assumptions – – – – – Resistance emerges through selective pressure Strict antibiotic control Closed population No patient to patient transmission No co-selection of resistance Antibiotic Cycling • Prospective cohort study conducted in ICU – University of Virginia • General, trauma, or transplant surgery patients • 2 year study – 1 year non-protocol driven antibiotic use – 1 year of rotating empirical antibiotic assignment • November 1997 – October 1999 Raymond DP, Crit Care Med 2001;29:1101 Antibiotic Cycling Quarter Pneumonia Jan-Mar Ciprofloxacin + Clindamycina Piperacillin / tazobactam Carbapenemb Apr-Jun Jul-Sep Oct-Dec Cefepime + Clindamycina Peritonitis / Sepsis of ? Etiology Carbapenemb Cefepime + Metronidazolec Ciprofloxacin + Clindamycina Piperacillin / tazobactam a - add clindamycin for pneumonia if aspiration suspected b – imipenem or meropenem c- add ampicillin or vancomycin if Enterococcus is suspected Raymond DP, Crit Care Med 2001;29:1101 Antibiotic Cycling Variable * Year 1 Year 2 p value Resistant GPC Infections 14.6 Resistant GNB Infections 7.7 Infection-related mortality 9.6 7.8 2.5 2.9 <0.001 <0.001 <0.001 Liver disease Transplantation 8 (5.6%) 6 (4.2%) <0.001 0.001 19 (10.8%) 27 (15.3%) * All variables per 100 admissions Limitations Concurrent ceftazidime to cefepime formulary switch Concurrent infection control interventions Raymond DP, Crit Care Med 2001;29:1101 Potential Strategies • Guidelines • Antibiotic cycling • Antimicrobial optimization Antimicrobial Optimization • Decrease unnecessary antibiotic use • Develop / apply guidelines for antibiotic use • Tailor empiric antibiotic selection to particular situation – Patient specific • Maintain broad choice of agents • Several approaches – Human – Computer Antimicrobial Optimization • Decrease unnecessary antibiotic use • Develop / apply guidelines for antibiotic use • Tailor empiric antibiotic selection to particular situation – Patient specific • Maintain broad choice of agents • Several approaches – Human – Computer Antibiotic Management Programs • University of Pennsylvania • 1993 - Antibiotic management program (AMP) – Formulary redesigned – Guidelines developed – AMT team • Approval of restricted agents • Streamlining of therapy Gross R, Clin Infect Dis 2001;33:289 Antibiotic Management Programs Outcome P value Appropriate AMT ID Fellows Adjusted OR (n=87) (n=93 (95%CI 76 44 7.7 (3.7, 16.2) Cure 49 0.03 35 2.4 (1.3, 4.5) <0.001 Gross R, Clin Infect Dis 2001;33:289 Antimicrobial Optimization • Decrease unnecessary antibiotic use • Develop / apply guidelines for antibiotic use • Tailor empiric antibiotic selection to particular situation – Patient specific • Maintain broad choice of agents • Several approaches – Human – Computer Computer Support Computer Decision Support • Prospective before-after study of a computerized anti-infectives management program • 12-bed ICU • LDS Hospital, Salt Lake City • June 1992 – June 1995 – 2 year “before” period – 1 year “after” period Evans RS, NEJM 1998;338:232 Computer Decision Support • Computer system – Data incorporated • Patient information: admission diagnosis, WBC count, temperature, surgical data, chest radiograph, microbiology data, pathology data, serologic data, allergies, past infection • Institution information: 5-year antibiogram – Output • Suggest antibiotic regimen that would cover the identified and potential pathogens Evans RS, NEJM 1998;338:232 Computer Decision Support Variable Before (n=766) After (n=203)* p value # different abx ordered Duration of abx (hrs) # abx doses ICU Length of stay (ds) Total Length of stay Total hospital cost 2.0 (1.9, 2.1) 214 (177-251) 23.6 (20.3–26.9) 4.9 (4.1-5.8) 12.9 (11.5-14.4) $35K (31K-39K) 1.5 (1.3, 1.7) <0.001 103 (45-160) <0.001 11.4 (6.2-16.7) <0.001 2.7 (1.5-4.0) <0.001 10.0 (7.7-12.3) <0.001 $26K (20K-32K)<0.001 * Includes only those patients for whom computer regimen was followed Values are means per patient and 95%CIs Evans RS, NEJM 1998;338:232 Trends in Antimicrobial Prescribing •Cross sectional survey •National Ambulatory Medical Care Survey (NCAMS) Overall abx use Adults 13% 10% (p<0.001) Peds 33% 22% (p<0.001) Broad Spectrum abx use Adults 24% 48% (p<0.001) Peds 23% 40% (p<0.001) Steinman MA, Ann Intern Med 2003;138:525 Trends in Antimicrobial Prescribing Steinman MA, Ann Intern Med 2003;138:525 Conclusions • Antimicrobial resistance increasing • Negative impact of resistance on clinical outcomes • Many potential interventions – All require more study • Judicious use of current agents critical to preserve future use Emergence of Antimicrobial Resistance Ebbing Lautenbach, MD, MPH Assistant Professor of Medicine and Epidemiology Associate Hospital Epidemiologist, Hospital of the University of Pennsylvania Center for Clinical Epidemiology & Biostatistics University of Pennsylvania School of Medicine PENN