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Bacterial infections in specific patient populations:
an update for the infectious diseases consultant
Liver cirrhosis
Pierluigi Viale Infectious Disease Unit Teaching Hospital S. Orsola–Malpighi Bologna ItalyESCMID eLibrary
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The infectious risk in liver cirrhosis
• A CLINICAL-EPIDEMIOLOGICAL OVERVIEW
• THE PATHOGENESIS : ENDOGENOUS & EXOGENOUS RISK
• ETIOLOGIES and ANTIMICROBIAL RESISTANCE TRENDS
• MOVING TOWARD AN IMPROVED MANAGEMENT
CONTENTS
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ED Visits Related to Cirrhosis: A Retrospective Study of the NationwideEmergency Department Sample 2006 to 2011 Pant C et al, Medicine 2015; 94:e308
During the calendar years 2006 to 2011, there were an estimated total of 3,127,986 EDvisits associated with an ICD-9-CM diagnosis code of cirrhosis in 951 US hospitals. Themedian age of patients was 56 years (interquartile range (IQR) 16)
4
6
15.5
20.1
HRS
EVB
HE
INFECTION
Rates of Cirrhosis-Associated ED Visits
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Approximately 30% of cirrhotic patients admitted to thehospital have an infection or develop an infection during thehospitalization
(Fernandez J et al., Hepatology 2002)
Overall mortality of infected cirrhotic patients is 30.3% at1 month and 63% at 12 months.
(Arvaniti V et al., Gastroenterology 2010)
AN EPIDEMIOLOGICAL OVERVIEW
The infectious risk in liver cirrhosis
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Acute-on-chronic liver failure (ACLF)J Hepatol 2015;62: S131–S143
Acute-on-chronic liver failure (ACLF) is a recently recognized syndrome
characterized by acute decompensation of cirrhosis (ascites,
encephalopathy, gastrointestinal hemorrhage and/or bacterial
infections) and organ/system failure(s) (liver, kidney, brain, coagulation,
circulation and/or respiration) with extremely poor survival (28-day
mortality rate 30–40%).
Acute-on-chronic liver failure is caused by bacterial infection in32.8% of cases (Moreau R et al., Gastroenterology 2013)ESCMID eLibrary
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A short case report … FC 52 year old, HCV related cirrhosis
Last ambulatory check March, 18
Body Weight 96 kg
P.A. 130/80
R.R. 16
Mental status 0
Bilirubin 4.9 mg/dl
INR 1.45
Creatinine 0,68 mg/dl
ACLF-2 expected 90-day mortality: >50%
Hospital admission April, 3Hospital admission April 3
Body Weight 110 kg
P.A. 120/780
R.R. 24
Mental status 2
Bilirubin 13 mg/dl
INR 2.35
Creatinine 3,89 mg/dl
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SMALL INTESTINAL BACTERIAL OVERGROWTH and DYSBIOSIS
BLOOD
SPONTANEOUS BACTERIAL PERITONITIS
BLOODSTREAM INFECTION
BLOODSTREAM INFECTION
BLOOD
ASCITIC FLUID
MESENTERIC LYMPHONODES
ABNORMAL BACTERIAL TRANSLOCATION
CIRRHOSIS ASSOCIATED IMMUNE DYSFUNCTION
Jalan R et al J Hepatol. 2014;60:1310-24.
PATHOGENESIS : the endogenous riskThe infectious risk in liver cirrhosis
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PNEUMONIACR-BLOODSTREAM INFECTION
INVASIVE PROCEDURES
The infectious risk in liver cirrhosis
CAID
HIGH COLONIZATION RATE
SSTIENDOTIPSITIS
POST- SURGICAL INFECTIONS
PATHOGENESIS : the exogenous risk
DRUGS HIGH FREQUENCY
OF HOSPITAL ADMISSIONS
UTI
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Endogenous route Exogenous route
The infectious risk in liver cirrhosis The main involved microorganisms
PRIMARY BSI SBP
EnterobacteriaceaeEnterococcus spp Candida spp
PNEUMONIA
S. pneumoniaeH. influentiae
Non Fermentative Gram neg Enterobacteriaceae
SSTICR-BSI
S. AureusCoNS
POST SURGICAL INFECTIONS
S. aureus , CoNSEnterobacteriaceae
Candida spp
intense antibiotic exposure
ESLD related dysbiosis
CDAD
MDRO
ENDOTIPSITIS
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Bacterial infection in compensated viral cirrhosis impairs 5-year survival (ANRS CO12 CirVir prospective cohort) Nahon P et al, Gut, November 6, 2015
Prospective study involving 35 French centers, enrolling Child–Pugh class A patients with HCV orHBV proven cirrhosis without previous cirrhosis related complications .Overall 1672 patients were enrolled (HCV 1323, HBV 318, HCV-HBV 31), between 2006-12.
During a median follow-up of 43 months, 234 Bacterial Infections occurred in 171patients (5 year Cumulative Incidence: 12.9%).
Among infected patients 14.6% had septic shock.
BIs represented the third cause of death (14.1%) after liver failure and livercancer
Most BIs occurred as a first event prior to liver decompensation (n=140, 81.8%)and were community acquired (84.2%).ESCMID eLibrary
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Bacterial infection in compensated viral cirrhosis impairs 5-year survival (ANRS CO12 CirVir prospective cohort) Nahon P et al, Gut, November 6, 2015
OVERALL SURVIVAL
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Features associated with occurrence of BI according to Cox proportional hazards model
Variable OR 95% CI p
Age >50 1.72 1.10 to 2.68 0.017
Albumin <30 g/L 5.61 2.43 to 12.96 <0.001
Albumin 30-35 g/L 2.02 1.22 to 3.34 0.006
Positive viral load 2.60 1.72 to 3.92 <0.001
PPI 1.45 1.00 to 2.13 0.05
Bacterial infection in compensated viral cirrhosis impairs 5-year survival (ANRS CO12 CirVir prospective cohort) Nahon P et al, Gut, November 6, 2015
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Bacterial infection in compensated viral cirrhosis impairs 5-year survival (ANRS CO12 CirVir prospective cohort) Nahon P et al, Gut, November 6, 2015
INFECTIONS SITE
19
23
24
44
59
64
others
SSTI
SBP
GE
Pneumonia
UTI
MICROBIOLOGY (98 isolates)
56
43
% Gram POS
% Gram NEG
MDRO 31%
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Prevalence and Risk Factors of Infections by Multiresistant Bacteria in Cirrhosis:A Prospective Study Fernandez J et al, Hepatology 2012;55:1551-1561
A prospective evaluation in two series of patients with cirrhosis admitted with infection ordeveloping infection during hospitalization. The first series was studied between 2005 and2007 (507 bacterial infections in 223 patients) and the second between 2010 and 2011(162 bacterial infections in 110 patients).
2005-7 2010-11
MDR related infections 18% 33%
Enterococcus spp
MRSA
P. aeruginosa
ESBL
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EFFICACY OF CURRENTLY RECOMMENDED EMPIRICAL ANTIBIOTIC THERAPY
overall CA HCA HA
66% 83% 73% 40%
In HOSPITAL MORTALITY rates
MDR susceptible p
25% 12% .001
Prevalence and Risk Factors of Infections by Multiresistant Bacteria in Cirrhosis:A Prospective Study Fernandez J et al, Hepatology 2012;55:1551-1561
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Multivariate analysis. Factors indipendently associated to MDR infection
Variable HR 95% CI p
Nosocomial origin 4.43 2.29 - 8.59 <0.0001
Long-term norfloxacin prophylaxis 2.69 1.362 – 5.30 0.004
Previous use of β-lactams (90dd) 2.39 1.18 – 4.85 0.02
Recent infection by MDR pathogens (< 6 m) 2.45 1.04-5.81 0.04
Prevalence and Risk Factors of Infections by Multiresistant Bacteria in Cirrhosis:A Prospective Study Fernandez J et al, Hepatology 2012;55:1551-1561
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Risk factors for resistance to ceftriaxone and its impact on mortality incommunity, healthcare and nosocomial spontaneous bacterial peritonitis
Ariza X et al J Hepatol 2012; 56:825-32
Retrospective study of all spontaneous bacterial peritonitis episodes with positive blood and/orascitic culture (2001–2009): 246 episodes were analyzed in 200 patients : 34.6% community-acquired, 38.6% healthcare system-acquired and 26.8% hospital acquired.
7%
21%
41%
21%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Community-
acquired
Healthcare
associated
Hospital- acquired Overall
3rd Gen cephalosporines resistance among culture-positive SBP episodes
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Factors indipendently associated to 3rd gen cephalosporine resistance
Variable AOR 95%CI
Diabetes mellitus 2.52 1.18 - 5.35
Upper GI Bleeding 8.15 1.92 – 34.54
Hospital acquisition 2.54 1.19 - 5.42
Previous use of beta-lactams (90 days) 2.97 1.23 – 7.17
Risk factors for resistance to ceftriaxone and its impact on mortality incommunity, healthcare and nosocomial spontaneous bacterial peritonitis
Ariza X et al J Hepatol 2012; 56:825-32
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First-line treatment with cephalosporins in spontaneous bacterial peritonitis providespoor antibiotic coverage. Novovic S et al, Scand J Gastroenterol 2012;47:212-6
All patients with cirrhosis and a positive ascitic fluid culture, at three university hospitals inthe Copenhagen area during a 7-year period, were retrospectively analyzed
One hundred and forty cases with 187 microbiological isolates were identified.
Gram-positive cocci, n = 86 (45.9%)Enterobacteriaceae, n = 59 (31.7%)Aanaerobes, n = 14 (7.5%)Yeast, n = 12 (6.4%)
Overall antibiotic coverage 57% for cephalosporins73% for piperacillin-tazobactam72% for meropenem.
Mortality rates in patients withisolates S or R to the initialantibiotic treatment at 30 daysfollow-up were 35% and 55%,respectively (p = 0.017).
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In culture positive patients,only 58.1% of the patientsreceived adequate antibiotictherapy with respect tosusceptibility of the identifiedmicroorganism.
All patients with incorrectempirical antibiotic therapywere initially treated with 3rd
gen. cephalosporins covering70.2% of non-nosocomial and56.3% of nosocomial-acquiredSBP cases.
Microbiology and resistance in first episodes of spontaneous bacterial peritonitis: implications for management and prognosis.
Friedrich K et al J Gastroenterol Hepatol 2015 Dec 17 [Epub ahead of print]
Retrospective analysis of cases occurred during the years 2007 to 2013.Of the 311 patients included, 114 had a positive ascites culture
6.50
13.80
26.10 40.60
7.20 4.00
Streptococcus spp
Staphylococcus spp
Enterococcus spp
Enterobacteriaceae
Yeasts
others
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SPONTANEOUS BACTERIAL PERITONITIS
MICROBIOLOGICAL CONSIDERATIONS
Gram staining of peritoneal fluid is rarely helpful and is not recommended.
Classical culture techniques fail to grow bacteria in up to 65% of neutrocyticascites. Bedside inoculation of ascites into blood culture bottles and providinghigh volumes of ascites to microbiologist have been shown to increase thesensitivity to nearly 80%.
Separate and simultaneous blood cultures should be collected since 30 to 58%of SBP cases are associated with bacteraemia
Detection of bactDNA in ascites or serum was not associated with anenhanced incidence of SBP and does not appear to predict the developmentof bacterial infectionsESCMID eLibrary
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Microbiology and resistance in first episodes of spontaneous bacterial peritonitis: implications for management and prognosis.
Friedrich K et al J Gastroenterol Hepatol 2015 Dec 17 [Epub ahead of print]
Features associated with death/Ltx in SBP patients
according to Cox’s proportional hazards model.
univariate analysis multivariate analysis
OR [95% CI] OR [95% CI]
Positive microbial ascites culture 2.01 [1.50-2.70] 1.49 [1.09-2.03]
SBP hospital acquired 1.02 [.75-1.39]
MELD-Score at time of SBP 1.06 [1.05-1.08] 1.05 [1.03-1.07]
ICU-contact during SBP episode 2.26 [1.68-3.05] 1.36 [.96-1.93]
Retrospective analysis of 311 cases occurred during the years 2007 to 2013
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Increasing frequency of gram-positive cocci and gram-negative MDR- bacteria in spontaneous bacterial peritonitis Alexopoulou A et al, Liver Int. 2013: 33: 975–981
To assess possible recent changes of the bacteria causing SBP in cirrhotic patients, 47 cases during a 4-year-period (2008–2011) were retrospectively recorded.
Gram positive cocci 26 casesStreptococcus spp (n = 10)Enterococcus spp (n = 9) MS Staphylococcus aureus (n = 4) CoNS (n = 3)
Gram negative bacteria 20 casesE. coli (n = 8) K. pneumoniae (n = 5) S. marcescens (n = 3)C. koseri (n = 1) Non fermenting bacilli (n = 3)
KPC Kp (n = 4)
ESBL (n = 3)
MDR P. aeruginosa (n = 2)
9 (45%) MDR
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Etiology distribution
Epidemiology and Outcomes of Bloodstream Infection In Patients with CirrhosisBartoletti M et al, J Hepatol 2014;61:51-8
All consecutive BSIs in patients with liver cirrhosis at a single institution (A 1350-bed teachinghospital) form Jan 2008 to Jun 2012 were retrospectively analyzed. BSI episodes were identifiedin 162 patients. A total of 202 isolates were identified.
44
15 1411 10
Enterbacteriaceae Enterococci NF-GNB Stafilococci Candida
Preva
lenc
e (%)
7%
34%
44%
15%
pan S
ESBL
Q-R
KPC
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The ESKAPE gang
bacterial clones that:
• have acquired multiple resistance determinants (MDR/XDR phenotypes)
• retain a notable propensity for cross-transmission and spreadingplaying a relevant role in infections and in the dissemination of resistant determinants (low impact of resistance on epidemiological fitness high epidemiological risk)
• are associated to significant morbidity and mortality (low impact of resistance on clinical fitness high clinical risk)
Woodford et al - FEMS Microbiol Rev 2011ESCMID eLibrary
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MOVING TOWARD AN IMPROVED MANAGEMENT
Issues
Adequate and early prediction of infection
Risk Factors for mortality – grading of severity
Improved microbiological work-out
Empirical drugs choice
Peculiarity of PK/PD behavior of antimicrobials
The infectious risk in liver cirrhosis
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LIVER CIRRHOSIS: RISK FACTORS FOR BACTERIAL INFECTIONS
RISK FACTOR Reference
STAGE of CIRRHOSIS / BIOMARKERS
Bilirubin > 3.2 mg/dL PLT < 98000/mmc
Guarner Gastroenterology 1999Andreu M Gastroenterology 1993
protein levels in ascitic fluid <1.5 g/L Child-Turcotte-Pugh >9 MELD > 19Lymphocytes < 900/mmc
Fernandez J, Gastroenterology 2007
Ximenes RA, Am J Emerg Med, 2015
MEDICATIONS
Use of PPILong term exposure to antibiotics
O’ Leary J et al Clin Gastroenterol Hepatol 2015Nahon P et al, Gut 2015
PRECIPITATING EVENTS
Acute variceal hemorrage Bernard B, et al. Hepatology, 1999
Previous infection Fernandez J, Gastroenterology 2007 ESCMID eLibrary
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Potential tools for early detection of infection.
EASL position paper J Hepatology 2014;60:1310–24ESCMID eLibrary
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MOVING TOWARD AN IMPROVED MANAGEMENT
Issues
Adequate and early prediction of infection
Risk Factors for mortality – grading of severity
Improved microbiological work-out
Empirical drugs choice
Peculiarity of PK/PD behavior of antimicrobials
The infectious risk in liver cirrhosis
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SEVERE SEPSIS
SEPSIS
T° > 38.3 / < 36°C
pulse rate > 90 beats/minute
respiratory rate > 20 breaths/min
WBC > 12.000 / < 4.000/mmc
glycemia > 120 mg/dL
lactemia > 2 mmol/L
plasma C-reactive protein >2 SD above the normal value (0.5 mg/L)
plasma procalcitonin > 2 SD above the normal value (0.1 pg/ml)
refilling > 2 seconds
altered mental status
hypotension (systolic < 90 mmHg)
lactemia > 4 mmol/L
organ disfunction/s
hypotension despite 20-40 ml/kg 1^h
SEPSIS DEFINITION
SEPTIC SHOCK ESCMID eLibrary
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How to stratify the risk of mortality in patients with cirrhosis and bacterial infections?
LIMITATIONS of SEPSIS CRITERIA
• Low WBC and PLTs count may be due to portal hypertension and hypersplenism
• Acute Phase protein are less accurate (reduction liver synthesis)
• Hyperventilation may be present in patients with large volume of ascites or incase of hepatic encephalopathy
• Liver disease slows lactate removal
• Normal hearth rate may be the consequence of prophylaxis with beta-blockersor tachyardia can be due to hyperdynamic circulationESCMID eLibrary
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Are SIRS criteria useful for diagnosis of bacterial infections in cirrhotic patients?
Cazzaniga M et al Journal of Hepatology 2009Thabut D et al Hepatology 2007
In a signle-center studypatients with ESLDconsecutively admitted tohospital were enrolled
Only 57% patients with infection met SIRS criteria
Multicenter prospectivestudy with the aim todetermine the prognosticfactors in a population ofpatients with cirrhosis andfunctional renal failureenrolling 83 pts
56% of patients with SIRS had an infection
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CLIF SOFA define 4 groups of patients with ACLF based on number of organ failuresNO ACLF ACLF 1ACLF 2ACLF 3
Acute-on-Chronic Liver Failure Is a Distinct Syndrome That Develops in patientsWith Acute Decompensation of Cirrhosis Moreau R et al, Gastroenterology 2013 ;144:1426-37
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MELD score as prognostic index for 30-day survival
Baseline 24h 48h 72h 96hdiagnosis
Median
MELD +
/-95% C
I
Time of Assessment
10
15
20
25
30
35 Non-survivors Day 30; n=47 (29%)
Survivors Day 30; n=115 (71%)
A retrospective analysis of all consecutive BSIs in patients with liver cirrhosis at our 1350-bed teaching hospital (Jan 2008 to Jun 2012): 162 cases detected (11.7 per 10,000 patient-days)
Epidemiology and Outcomes of Bloodstream Infection In Patients with CirrhosisBartoletti M et al, J Hepatol 2014;61:51-8
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0 20 40 60 80 100
0
20
40
60
80
100
100-Specificity
Sen
sitivity
Variable aROC (95% CI)
MELD at BSI 0.81 (0.74-0.87)
∆ MELD at BSI 0.89 (0.83-0.94)
∆ MELD 24h 0.54 (0.45-0.62)
∆ MELD 48h 0.66 (0.56-0.76)
∆ MELD 72h 0.76 (0.66-0.86)
∆ MELD BSI
∆ MELD 72h
∆ MELD 48h
∆ MELD 24h
MELD at BSI
Comparison of aROC for MELDscore variables as a predictor of30-day survival status
Δ MELD was evaluable in 150 patients, 9±6 in NS vs. 2±3 in S, P<0.0001
Epidemiology and Outcomes of Bloodstream Infection In Patients with CirrhosisBartoletti M et al, J Hepatol 2014;61:51-8
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Kaplan-Meier analysis of 30-day crude mortality stratified by Δ MELD.
Epidemiology and Outcomes of Bloodstream Infection In Patients with CirrhosisBartoletti M et al, J Hepatol 2014;61:51-8
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MOVING TOWARD AN IMPROVED MANAGEMENT
Issues
Adequate and early prediction of infection
Risk Factors for mortality – grading of severity
Improved microbiological work-out
Empirical drugs choice
Peculiarity of PK/PD behavior of antimicrobials
The infectious risk in liver cirrhosis
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Adjusted HR 0.37 (0.20-0.70)
P =0.002
Adequate antibiotic therapy
within 24 hours (n=100)
Inadequate antibiotic therapy
within 24 hours (n=62)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
Surv
ival P
robabili
ty
0 5 10 15 20 25 30
Days after positive blood culture
Impact of inadequate antimicrobial therapy in the first 24 hours on survival
Epidemiology and Outcomes of Bloodstream Infection In Patients with CirrhosisBartoletti M et al, J Hepatol 2014;61:51-8
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Clinical features and impact of empirical therapy in cirrhotic adults with community-onset bacteremia. Hsieh C et al ,Am J Emerg Med. 2015;33:222-8
246 bacteremic episodes in cirrhotic patients
* Delayed: after 72 h from BSI
symptoms onset
*
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An Empirical Broad Spectrum Antibiotic Therapy in Health-Care–AssociatedInfections Improves Survival in Patients With Cirrhosis: A Randomized Trial
Merli M et al Hepatology , 2015 Nov 3.
In-hospital mortality showed a substantial reduction
in the broad spectrum versus standard group (6% vs. 25%; P<0.01)
Ninety-four patients with HCA infections were randomized to receive :1-standard treatment or 2-broad spectrum antibiotic treatment
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The Empirical Antibiotic Treatment of Nosocomial Spontaneous BacterialPeritonitis: Results of a Randomized, Controlled Clinical Trial
Piano S et al, Hepatology 2016;63:1299-1309
Patients with cirrhosis and nosocomial SBP were randomized to receive meropenem (1g/8 hours) plus daptomycin (6 mg/kg/day) or ceftazidime (2 g/8 hours). The primaryoutcome was the efficacy of treatment defined by the resolution of SBP after 7days of treatment. Thirty-two patients were randomized and 31 were analyzed.
resolution rates
Combo 86.7 %
Mono 25.0 % P < 0.001
Probability of 90-day TFS according to efficacy of first line treatmentESCMID eLibrary
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MOVING TOWARD AN IMPROVED MANAGEMENT
Issues
Adequate and early prediction of infection
Risk Factors for mortality – grading of severity
Improved microbiological work-out
Empirical drugs choice
Peculiarity of PK/PD behavior of antimicrobials
The infectious risk in liver cirrhosis
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Ensuring a prompt and appropriate empirical antimicrobialtreatment is essential in every severe infection
On the whole, pharmacokinetic variability is one of the
major contributors to therapeutic failure: therefore to
guarantee a correct exposure to antibiotics, timely
administration of the right dose at the right schedule,
according to the pathophysiological and immunological
status of the patient, is required.
Ensuring a prompt and appropriate empirical antimicrobialtreatment is mandatory in every infection occurring in Liver CirrhosisESCMID eLibrary
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Altered protein binding• Hypoproteinemia (albumin, α-acid glycoprotein)
• Elevated binding competitors (bilirubin)
• Increased Vd
Altered distribution• Increased extracellular fluid (edema, ascites)
• Increased Vd → low serum conc. → prolonged clearance
• Unpredictable serum levels
Altered renal function• GFR < 60 mL/min despite normal SeCr
• Cockcroft-Gault estimation 2-3x higher than actual GFR
• Impaired creatinine production
Impact of liver cirrhosis on antimicrobial PK/PD behavior
Given the unpredictable
drug exposure, TDM
might play a pivotal role
for individualizing doses,
both in lowering exposure-
dependent toxicity and in
ensuring an optimal drug
exposure, especially when
MDR pathogens are
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Avoid third generation cephalosporines and fluoroquinolones as empirical therapy, atleast in healthcare-associated and hospital acquired infections
Use a BL/BLI in setting with low-intermediate prevalence of ESBL producing strainsor for less severe infections (when you have the opportunity to graduate them)
Start with a carbapenem in settings with high prevalence of ESBL producing strainsattempting to de-escalate as soon as culture results become available or clinicalstability is reached
Provide anti-MR cocci drugs in pts with suspected device related infections and SBP
If time-dependent drugs (e.g., b-lactams) are administered, provide a loading doseand continuous or extended infusion;
Assess, whenever possible, drug exposure by TDM.
remarks for empirical antimicrobial treatment
Bartoletti M et al. Virulence 2016 Feb 11:0. [Epub ahead of print]ESCMID eLibrary
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Alma Mater Studiorum University of Bologna – The Library
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