NEXT STEP TO STOP THE SPREAD OF ANTIMICROBIAL RESISTANCE. Patricia Ruiz Garbajosa Servicio de Microbiología Hospital Universitario Ramón y Cajal

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1 NEXT STEP TO STOP THE SPREAD OF ANTIMICROBIAL RESISTANCE Patricia Ruiz Garbajosa Servicio de Microbiología Hospital Universitario Ramón y Cajal

2 ANTIMICROBIAL RESISTANCE AND HEALTHCARE-ASSOCIATED INFECTION Approximately 4 million patients acquire an HAI each year in the EU death as a direct result of the infection by a multidrug-resistant (MDR) bacteria Patient Safety International and national strategies against antimicrobial resistance specific_programmes_ pdf

3 ANTIMICROBIAL RESISTANCE: CLINICAL RELEVANCE Increasing costs - higher length of hospital stay - higher antimicrobial use, most in combinations (side effects) Increasing mortality - patients at risk (risk factors for colonization/infection) - treatment failure Navarro-San Francisco et al. CMI 2013; 19:E72-9; Muñoz-Price et al. LID 2013; 13:785-96

4 FOUR CORE ACTIONS TO PREVENT ANTIBIOTIC RESISTANCE Preventing infections and preventing the spread of resistant bacteria Tracking resistant bacteria Improving the use of antibiotics Promoting the development of new antibiotics and developing new diagnostic tests for resistant bacteria ANTIBIOTIC RESISTANCE THREATS (CDC) in the United States WHO - Antimicrobial resistance: global report on surveillance. 2014

5 CONTROL AND PREVENTION OF ANTIMICROBIAL RESISTANCE IN HOSPITALS Selection of MDR-bacteria by antibiotic use Spread and crosstransmission of MDR-bacteria Prudent use of antibiotic Stewardship programs Infection control policies Detection of antimicrobial resistance

6 CARBAPENEMASE-PRODUCING ENTEROBACTERIACEAE PARADIGM OF MULTIFRUG-RESISTANT BACTERIA Responsible of the increment of resistance to carbapenems Klebsiella pneumoniae h"p:// Net/database/Pages/map_reports.aspx

7 CARBAPENEMASES: THE COMPLEXITY Complex detection -Different molecular groups (different hydrolysing/inhibition profile) -Variable expression of carbapenem resistance - different MIC values - heterorresistance -Variable detection by commercial systems -Other resistance mechanismis (ESBL, AMPc..) Complex epidemiology - Increasing prevalence worldwide - Different enzymes in different geographic areas but towards globalization - Cross border transmission of carbapenemase producing isolates - Dispersion of high-risk-clones but with esporadic clones - Associated with specific horizontal gene plattforms (plasmids, )

8 CARBAPENEMASES: ENZYMES DISTRIBUTION IN EUROPE ECDC. Carbapenemase-producing bacteria in Europe: interim results from the EuSCAPE project

9 CARBAPENEMASE-PRODUCING ENTEROBACTERIACEAE Which are the challenges for the clinical microbiology laboratories and infection control teams? Implementation of international/local guidelines Rapid detection and recognition of CPE Selection of samples (outbreaks / active surveillance)

10 EUROPEAN SURVEY 38 European countries The purpose of the survey: Information about the spread of CPE in Europe Available national guidelines Laboratory capacity for diagnosis Surveillance systems at national and European level Only 55% (21/38) of EU countries declare to have specific guidelines on infection, prevention and control measures to prevent the spread of CPE

11 ESCMID INFECTIOUS CONTROL GUIDELINES (2014) EU guidelines prescriptions in endemic and epidemic situations Guidelines Contact Precautions (CP) 1 Preventive CP / isolation Isolation room if positive Environmen tal cleaning Cohort patients Cohort Staff Active screening culture at admission Antimicrobial stewardship 2 In endemic situation (m) (m) (m) (m) (m) In case of outbreak (m) (m) (m) (m) (m) (m) (m) (l) Strong recommendation Conditional recommendation (m): moderate level of evidence (l): low level of evidence Source: European Society of Clinical Microbiology and Infectious Diseases (2014)

12 EUROPEAN SURVEY 38 European countries The purpose of the survey: Information about the spread of CPE in Europe Available national guidelines Laboratory capacity for diagnosis Surveillance systems at national and European level Only 55% (21/38) of EU countries declare to have specific guidelines on infection, prevention and control measures to prevent the spread of CPE

13 REGIONAL PLAN FOR PREVENTION AND CONTROL OF CPE Comunidad de Madrid

14 RECOMMENDATIONS FOR ACTIVE SURVEILLANCE IN COMUNIDAD DE MADRID REGIONAL PLAN Active surveillance is recommended for high risk populations: UCI and trasplant units Contact of CPE carriers Patients transferred from another hospital Patients transferred from LTCF Patients hospitalized in wards with high CPE prevalence Rapid detection and recognition of CPE

15 WORKFLOW FOR CPE DETECTION Bacterial isolation (chromogenic media, selective broth, plates with a carbapenem disk, ) Detection of carbapenemase production - colorimetric tests (NP-test) - cloverleaf (modified Hodge) test MIC-disk testing and phenotypic classification* t 0 t t 48 Meropenem<25 mm with diskdiffusion or MIC >0.12 mg/l in all Enterobacteriaceae Synergy with APBA/PBA only Synergy with APBA/ PBA AND cloxacillin Synergy with DPA/EDTA only No synergy KPC (or other class A carbapenemase) AmpC (chromosomal and plasmid-acquired) AmpC plus porin loss Metallo-betalactamase (MBL) Confirmation/characterization (molecular testing) ESBL plus porin loss AND OXA-48 *EUCAST guidelines t 72 t >72

16 Xpert Carba- R Assay Cartridge detects 5 classes of carbapenem resistance genes: - bla KPC, bla NDM, bla VIM, bla IMP-1, bla OXA-48 + bla OXA-181 Sample: Rectal swabs Time to result: 48 minutes

17 Xpert Carba- R Assay WORKFLOW Rectal swab Sample Buffer Result in 48 min Detection, confirmation and characterization in 48 minutes

18 J Clin Microbiol 2013; 51: (rectal, perirectal, stool) specimens (center: 2 US, 1 Spain) Culture reference method - MacConkey agar plate + 10 µg-meropenem disk - 10 ml MacConkey broth + 10 µg-meropenem disk Xpert MDRO for detecting bla KPC, bla NDM, and bla VIM 13.1% and 3.4% positive by PCR for bla KPC and bla VIM Diagnostic values (GeneXpert cartridged-xpert MDRO assay) Sensitivity Specificity PPV PNV bla KPC 100% 99.0% 93.0% 100% bla VIM 100% 99.4% 81.8% 100

19 Xpert Carba-R Assay ON-GOING EVALUATION (PRELIMINARY RESULTS) 186 rectal swabs Local culture method - chromid ESBL, chromid CARBA and chromid OXA-48 Reference culture method Xpert detecting bla KPC, bla NDM, bla VIM, bla IMP-1, bla OXA % (37/186) positive - 26 OXA-48; 4 VIM, 3 KPC, 4 OXA-48+VIM Comparative results of Xpert Carba-R assay with local culture - 28 PCR positive with culture positive - 9 PCR-positive with culture negative - 1 PCR-negative with culture positive

20 CE Clinical Trial Data for Xpert Carba-R Participants: Spain, Italy, UK and Israel Samples: 633 rectal swabs Samples with two resistance genes detected Target PosiWve SensiWvity (%) NegaWve Specificity (%) KPC 28/ / VIM 28/ / NDM 26/ / OXA / / IMP- 1 26/ /

21 Advantages -Rapid turnaround Rapid detection and information -Easy workflow: Save technician time -Resolve complex phenotypes -Increased sensitivity/specificity -Cost-benefit Disadvantages -Cost-benefit analysis is required -Duplicity of techniques: Culture is still necessary resistance phenotype, carbapenems MICs, bacterial identification, molecular epidemiology studies.

22 COSTS ANALYSIS FOR 3 DAYS OF INFECTION CONTROL MEASURES $ 217 per patient for 3 days isolation $ 924 per patient for 3 days isolation Contact Precautions $ 191,5 Housekeeping time $ 25,5 Private Room $ 696 Contact Precautions $ 191,5 Infection Control time $ 11,5 Housekeeping time $26 $ 72 per day per patient $ 308 per day per patient Rajapakse N1, et al. Infect Control Hosp Epidemiol Apr;35(4):450-1.

23 In our experience CARBAPENEMASE-PRODUCING ENTEROBACTERIACEAE Key points to introduce rapid molecular methods (balance between sensitivity and expense for CPE detection) 1) Knowledge of local epidemiology Local Prevalence Microbiological characteristics (types of enzymes,bacterial species ) 2) Well-define target population 3) Implementation of working plan in the hospital Importance of detection of fecal carriers for the management of patients in the health sanitary systems

24 CARBAPENEMASE-PRODUCING ENTEROBACTERIACEAE Conclusions Complex classification and epidemiology Increasing prevalence allover the world - towards globalization and increasing complexity International public health concern - associated with mortality and with economic costs Importance of detection of fecal carriers for the management of patients in the health sanitary systems Implementation of rapid and accurate tests for detection of fecal carriers (Xpert system)

25 NEXT STEP TO STOP THE SPREAD OF ANTIMICROBIAL RESISTANCE Patricia Ruiz Garbajosa Servicio de Microbiología Hospital Universitario Ramón y Cajal

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