The role of infection models and PK/PD modelling for optimising care of critically ill patients with severe infections

Intensive Care Medicine

Volumn 43, Issue 7, 2017, Pages 1021-1032

  Tangden T ^a   Ramos Martin V ^b   Felton, T W ^c   Nielsen, E I ^a   Marchand, S ^d,e   Bruggemann R J ^f   Bulitta, J B ^g   Bassetti, M ^h   Theuretzbacher, U ⁱ   Tsuji, B T ^j   Wareham, D W ^k   Friberg, L E ^a   De Waele, J J ^l   Tam, V H ^m   Roberts, Jason A ^n,o  

^a UPPSALA UNIVERSITY   (Sweden)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

^c MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^d INSERM   (France)

^e UNIVERSITÉ DE POITIERS   (France)

^f RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^g UNIVERSITY OF FLORIDA HEALTH   (United States)

^h SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

ⁱ Center For Anti Infective Agents Vienna   (Austria)

^j UNIVERSITY AT BUFFALO   (United States)

^k QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^l GHENT UNIVERSITY HOSPITAL   (Belgium)

^m UNIVERSITY OF HOUSTON   (United States)

ⁿ UNIVERSITY OF QUEENSLAND   (Australia)

^o ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

more..

Author keywords

Antibiotics; Individualised dosing; Mathematical modelling; Pharmacodynamics; Pharmacokinetics

Indexed keywords

ANTIINFECTIVE AGENT; CIPROFLOXACIN; CREATININE; GENTAMICIN; LINEZOLID; MEROPENEM; PIPERACILLIN PLUS TAZOBACTAM; VANCOMYCIN; AMINOGLYCOSIDE; BETA LACTAM; BIOLOGICAL MARKER; GLYCOPEPTIDE; QUINOLONE DERIVATIVE;

ANTIBIOTIC THERAPY; AREA UNDER THE CURVE; CONTINUOUS RENAL REPLACEMENT THERAPY; CREATININE CLEARANCE; CRITICALLY ILL PATIENT; DRUG EXPOSURE; DRUG MONITORING; EXTRACORPOREAL OXYGENATION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INFECTION; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; PHARMACODYNAMICS; PLASMA CONCENTRATION-TIME CURVE; REVIEW; SAMPLING; TREATMENT OUTCOME; VOLUME OF DISTRIBUTION; ANIMAL; BLOOD; CRITICAL ILLNESS; DISEASE MODEL; DOSE RESPONSE; INTENSIVE CARE UNIT; PROCEDURES; SEVERITY OF ILLNESS INDEX;

AMINOGLYCOSIDES; ANIMALS; ANTI-BACTERIAL AGENTS; BETA-LACTAMS; BIOMARKERS; CRITICAL ILLNESS; DISEASE MODELS, ANIMAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; GLYCOPEPTIDES; HUMANS; INTENSIVE CARE UNITS; QUINOLONES; SEVERITY OF ILLNESS INDEX;

EID: 85017432849     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-017-4780-6     Document Type: Review

References (75)

1. Gohil SK, Cao C, Phelan M, Tjoa T, Rhee C, Platt R, Huang SS, Centers for Disease Control and Prevention Epicenters Program (2016) Impact of policies on the rise in sepsis incidence, 2000–2010. Clin Infect Dis 62:695–703
2. Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K, EPIC II Group of Investigators (2009) International study of the prevalence and outcomes of infection in intensive care units. JAMA 302:2323–3239
3. Udy AA, Roberts JA, Lipman J (2013) Clinical implications of antibiotic pharmacokinetic principles in the critically ill. Intensive Care Med 39:2070–2082
4. Roberts JA, Abdul-Aziz MH, Lipman J, Mouton JW, Vinks AA, Felton TW, Hope WW, Farkas A, Neely MN, Schentag JJ, Drusano G, Frey OR, Theuretzbacher U, Kuti JL, International Society of Anti-Infective Pharmacology and the Pharmacokinetics and Pharmacodynamics Study Group of the European Society of Clinical Microbiology and Infectious Diseases (2014) Individualised antibiotic dosing for patients who are critically ill: challenges and potential solutions. Lancet Infect Dis 14:498–509
5. Kwa AL, Low JG, Lee E, Kurup A, Chee HL, Tam VH (2007) The impact of multidrug resistance on the outcomes of critically ill patients with Gram-negative bacterial pneumonia. Diagn Microbiol Infect Dis 58:99–104
6. Muller AE, Theuretzbacher U, Mouton JW (2015) Use of old antibiotics now and in the future from a pharmacokinetic/pharmacodynamic perspective. Clin Microbiol Infect 21:881–885
7. Mouton JW, Brown DF, Apfalter P, Cantón R, Giske CG, Ivanova M, MacGowan AP, Rodloff A, Soussy CJ, Steinbakk M, Kahlmeter G (2012) The role of pharmacokinetics/pharmacodynamics in setting clinical MIC breakpoints: the EUCAST approach. Clin Microbiol Infect 18:e37–e45
8. EUCAST. Antimicrobial susceptibility testing. http://www.eucast.org/ast_of_bacteria/. Accessed 15 Jan 2017
9. Clinical and Laboratory Standards Institute (CLSI) (2015) M100-S25: Performance standards for antimicrobial susceptibility testing; 25th informational supplement. CLSI, Wayne
10. Zhao X, Drlica K (2001) Restricting the selection of antibiotic-resistant mutants: a general strategy derived from fluoroquinolone studies. Clin Infect Dis 33:S147–S156
11. Craig WA (1998) Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 26:1–10
12. Drusano GL (2004) Antimicrobial pharmacodynamics: critical interactions of bug and drug. Nat Rev Microbiol 2:289–300
13. Barger A, Fuhst C, Wiedemann B (2003) Pharmacological indices in antibiotic therapy. J Antimicrob Chemother 52:893–898
14. Mouton JW, Dudley MN, Cars O, Derendorf H, Drusano GL (2005) Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs: an update. J Antimicrob Chemother 55:601–607
15. National Committee for Clinical Laboratory Standards (NCCLS) (1999) M26-A: Methods for determining bactericidal activity of antimicrobial agents; approved guideline. NCCLS, Wayne
16. Bergen PJ, Forrest A, Bulitta JB, Tsuji BT, Sidjabat HE, Paterson DL, Li J, Nation RL (2011) Clinically relevant plasma concentrations of colistin in combination with imipenem enhance pharmacodynamic activity against multidrug-resistant Pseudomonas aeruginosa at multiple inocula. Antimicrob Agents Chemother 55:5134–5142
17. Gloede J, Scheerans C, Derendorf H, Kloft C (2010) In vitro pharmacodynamic models to determine the effect of antibacterial drugs. J Antimicrob Chemother 65:186–201
18. Tam VH, Louie A, Deziel MR, Liu W, Drusano GL (2007) The relationship between quinolone exposures and resistance amplification is characterized by an inverted U: a new paradigm for optimizing pharmacodynamics to counterselect resistance. Antimicrob Agents Chemother 51:744–747
19. Zinner SH, Husson M, Klastersky J (1981) An artificial capillary in vitro kinetic model of antibiotic bactericidal activity. J Infect Dis 144:583–587
20. Tsuji BT, Bulitta JB, Brown T, Forrest A, Kelchlin PA, Holden PN, Peloquin CA, Skerlos L, Hanna D (2012) Pharmacodynamics of early, high-dose linezolid against vancomycin-resistant enterococci with elevated MICs and pre-existing genetic mutations. J Antimicrob Chemother 67:2182–2190
21. Bergen PJ, Bulitta JB, Kirkpatrick CM, Rogers KE, McGregor MJ, Wallis SC, Paterson DL, Lipman J, Roberts JA, Landersdorfer CB (2016) Effect of different renal function on antibacterial effects of piperacillin against Pseudomonas aeruginosa evaluated via the hollow-fibre infection model and mechanism-based modelling. J Antimicrob Chemother 71:2509–2520
22. Nielsen EI, Friberg LE (2013) Pharmacokinetic-pharmacodynamic modeling of antibacterial drugs. Pharmacol Rev 26:1053–1090. doi:10.1124/pr.111.005769
23. Gonçalves-Pereira J, Póvoa P (2011) Antibiotics in critically ill patients: a systematic review of the pharmacokinetics of β-lactams. Crit Care 15:R206
24. Udy AA, Roberts JA, Boots RJ, Paterson DL, Lipman J (2010) Augmented renal clearance: implications for antibacterial dosing in the critically ill. Clin Pharmacokinet 49:1–16
25. Jamal JA, Economou CJ, Lipman J, Roberts JA (2012) Improving antibiotic dosing in special situations in the ICU: burns, renal replacement therapy and extracorporeal membrane oxygenation. Curr Opin Crit Care 18:460–471
26. Choi G, Gomersall CD, Tian Q, Joynt GM, Freebairn R, Lipman J (2009) Principles of antibacterial dosing in continuous renal replacement therapy. Crit Care Med 37:2268–2282
27. Shekar K, Fraser JF, Smith MT, Roberts JA (2012) Pharmacokinetic changes in patients receiving extracorporeal membrane oxygenation. J Crit Care 27:741.e9–741.e18
28. Roberts JA, Udy AA, Jarrett P, Wallis SC, Hope WW, Sharma R, Kirkpatrick CM, Kruger PS, Roberts MS, Lipman J (2015) Plasma and target-site subcutaneous tissue population pharmacokinetics and dosing simulations of cefazolin in post-trauma critically ill patients. J Antimicrob Chemother 70:1495–1502
29. Hope WW, Drusano GL (2009) Antifungal pharmacokinetics and pharmacodynamics: bridging from the bench to bedside. Clin Microbiol Infect 15:602–612
30. Ramos-Martín V, Paulus S, Siner S, Scott E, Padmore K, Newland P, Drew RJ, Felton TW, Docobo-Pérez F, Pizer B, Pea F, Peak M, Turner MA, Beresford MW, Hope WW (2014) Population pharmacokinetics of teicoplanin in children. Antimicrob Agents Chemother 58:6920–6927
31. Tam VH, Preston SL, Drusano GL (2003) Optimal sampling schedule design for populations of patients. Antimicrob Agents Chemother 47:2888–2891
32. Ryan DM, Cars O (1983) A problem in the interpretation of β-lactam antibiotic levels in tissues. J Antimicrob Chemother 12:281–284
33. Müller M, dela Peña A, Derendorf H (2004) Issues in pharmacokinetics and pharmacodynamics of anti-infective agents: distribution in tissue. Antimicrob Agents Chemother 48:1441–1453
34. Joukhadar C, Frossard M, Mayer BX, Brunner M, Klein N, Siostrzonek P, Eichler HG, Müller M (2001) Impaired target site penetration of β-lactams may account for therapeutic failure in patients with septic shock. Crit Care Med 29:385–391
35. Mouton JW, Theuretzbacher U, Craig WA, Tulkens PM, Derendorf H, Cars O (2008) Tissue concentrations: do we ever learn? J Antimicrob Chemother 61:235–237
36. Marchand S, Chauzy A, Dahyot-Fizelier C, Couet W (2016) Microdialysis as a way to measure antibiotics concentration in tissues. Pharmacol Res 111:201–207
37. Dahyot-Fizelier C, Frasca D, Gregoire N, Adier C, Mimoz O, Debaene B, Couet W, Marchand S (2013) Microdialysis study of cefotaxime cerebral distribution in patients with acute brain injury. Antimicrob Agents Chemother 57:2738–2742
38. Dahyot-Fizelier C, Lefeuvre S, Laksiri L, Marchand S, Sawchuk RJ, Couet W, Mimoz O (2010) Kinetics of imipenem distribution into the peritoneal fluid of patients with severe peritonitis studied by microdialysis. Clin Pharmacokinet 49:323–334
39. Panidis D, Markantonis SL, Boutzouka E, Karatzas S, Baltopoulos G (2005) Penetration of gentamicin into the alveolar lining fluid of critically ill patients with ventilator-associated pneumonia. Chest 128:545–552
40. Boselli E, Breilh D, Rimmelé T, Poupelin JC, Saux MC, Chassard D, Allaouchiche B (2004) Plasma and lung concentrations of ceftazidime administered in continuous infusion to critically ill patients with severe nosocomial pneumonia. Intensive Care Med 30:989–991
41. Boselli E, Breilh D, Duflo F, Saux MC, Debon R, Chassard D, Allaouchiche B (2003) Steady-state plasma and intrapulmonary concentrations of cefepime administered in continuous infusion in critically ill patients with severe nosocomial pneumonia. Crit Care Med 31:2102–2106
42. Tomaselli F, Maier A, Matzi V, Smolle-Jüttner FM, Dittrich P (2004) Penetration of meropenem into pneumonic human lung tissue as measured by in vivo microdialysis. Antimicrob Agents Chemother 48:2228–2232
43. Tomaselli F, Dittrich P, Maier A, Woltsche M, Matzi V, Pinter J, Nuhsbaumer S, Pinter H, Smolle J, Smolle-Jüttner FM (2003) Penetration of piperacillin and tazobactam into pneumonic human lung tissue measured by in vivo microdialysis. Br J Clin Pharmacol 55:620–624
44. Zeitlinger MA, Traunmüller F, Abrahim A, Müller MR, Erdogan Z, Müller M, Joukhadar C (2007) A pilot study testing whether concentrations of levofloxacin in interstitial space fluid of soft tissues may serve as a surrogate for predicting its pharmacokinetics in lung. Int J Antimicrob Agents 29:44–50
45. Lamer C, de Beco V, Soler P, Calvat S, Fagon JY, Dombret MC, Farinotti R, Chastre J, Gibert C (1993) Analysis of vancomycin entry into pulmonary lining fluid by bronchoalveolar lavage in critically ill patients. Antimicrob Agents Chemother 37:281–286
46. Bulik CC, Wiskirchen DE, Shepard A, Sutherland CA, Kuti JL, Nicolau DP (2010) Tissue penetration and pharmacokinetics of tigecycline in diabetic patients with chronic wound infections described by using in vivo microdialysis. Antimicrob Agents Chemother 54:5209–5213
47. Kim A, Suecof LA, Sutherland CA, Gao L, Kuti JL, Nicolau DP (2008) In vivo microdialysis study of the penetration of daptomycin into soft tissues in diabetic versus healthy volunteers. Antimicrob Agents Chemother 52:3941–3946
48. Boselli E, Breilh D, Rimmelé T, Djabarouti S, Toutain J, Chassard D, Saux MC, Allaouchiche B (2005) Pharmacokinetics and intrapulmonary concentrations of linezolid administered to critically ill patients with ventilator-associated pneumonia. Crit Care Med 33:1529–1533
49. Duffull SB, Wright DF, Winter HR (2011) Interpreting population pharmacokinetic-pharmacodynamic analyses—a clinical viewpoint. Br J Clin Pharmacol 71:807–814
50. Kiang TK, Sherwin CM, Spigarelli MG, Ensom MH (2012) Fundamentals of population pharmacokinetic modelling: modelling and software. Clin Pharmacokinet 51:515–525
51. Drusano GL, Preston SL, Hardalo C, Hare R, Banfield C, Andes D, Vesga O, Craig WA (2001) Use of preclinical data for selection of a phase II/III dose for evernimicin and identification of a preclinical MIC breakpoint. Antimicrob Agents Chemother 45:13–22
52. Kristoffersson AN, David-Pierson P, Parrott NJ, Kuhlmann O, Lave T, Friberg LE, Nielsen EI (2016) Simulation-based evaluation of PK/PD indices for meropenem across patient groups and experimental designs. Pharm Res 33:1115–1125
53. Li C, Du X, Kuti JL, Nicolau DP (2007) Clinical pharmacodynamics of meropenem in patients with lower respiratory infections. Antimicrob Agents Chemother 51:1725–1730
54. Lodise TP, Sorgel F, Melnick D, Mason B, Kinzig M, Drusano GL (2011) Penetration of meropenem into epithelial lining fluid of patients with ventilator-associated pneumonia. Antimicrob Agents Chemother 55:1606–1610
55. De Waele J, Carlier M, Hoste E, Depuydt P, Decruyenaere J, Wallis SC, Lipman J, Roberts JA (2014) Extended versus bolus infusion of meropenem and piperacillin: a pharmacokinetic analysis. Minerva Anestesiol 80:1302–1309
56. Rhodes NJ, O’Donnell JN, Lizza BD, McLaughlin MM, Esterly JS, Scheetz MH (2015) Tree-based models for predicting mortality in gram-negative bacteremia: avoid putting the CART before the horse. Antimicrob Agents Chemother 23:838–844
57. Aitken SL, Altshuler J, Guervil DJ, Hirsch EB, Ostrosky-Zeichner LL, Ericsson CD, Tam VH (2015) Cefepime free minimum concentration to minimum inhibitory concentration (fCmin/MIC) ratio predicts clinical failure in patients with Gram-negative bacterial pneumonia. Int J Antimicrob Agents 45:541–544
58. Lestner JM, Roberts SA, Moore CB, Howard SJ, Denning DW, Hope WW (2009) Toxicodynamics of itraconazole: implications for therapeutic drug monitoring. Clin Infect Dis 49:928–930
59. Neely MN, Youn G, Jones B, Jelliffe RW, Drusano GL, Rodvold KA, Lodise TP (2014) Are vancomycin trough concentrations adequate for optimal dosing? Antimicrob Agents Chemother 58:309–316
60. Colin P, Eleveld DJ, Jonckheere S, Van Bocxlaer J, De Waele J, Vermeulen A (2016) What about confidence intervals? A word of caution when interpreting PTA simulations. J Antimicrob Chemother 71:2502–2508
61. Roberts JA, Taccone FS, Udy AA, Vincent JL, Jacobs F, Lipman J (2011) Vancomycin dosing in critically ill patients: robust methods for improved continuous-infusion regimens. Antimicrob Agents Chemother 55:2704–2709
62. Cristallini S, Hites M, Kabtouri H, Roberts JA, Beumier M, Cotton F, Lipman J, Jacobs F, Vincent JL, Creteur J, Taccone FS (2016) New regimen for continuous infusion of vancomycin in critically ill patients. Antimicrob Agents Chemother 60:4750–4756
63. Wong G, Farkas A, Sussman R, Daroczi G, Hope WW, Lipman J, Roberts JA (2015) Comparison of the accuracy and precision of pharmacokinetic equations to predict free meropenem concentrations in critically ill patients. Antimicrob Agents Chemother 59:1411–1417
64. Jager NG, van Hest RM, Lipman J, Taccone FS, Roberts JA (2016) Therapeutic drug monitoring of anti-infective agents in critically ill patients. Expert Rev Clin Pharmacol 9:961–979
65. Zavascki AP, Bulitta JB, Landersdorfer CB (2013) Combination therapy for carbapenem-resistant Gram-negative bacteria. Expert Rev Anti Infect Ther 11:1333–1353
66. Tsuji BT, Brown T, Parasrampuria R, Brazeau DA, Forrest A, Kelchlin PA, Holden PN, Peloquin CA, Hanna D, Bulitta JB (2012) Front-loaded linezolid regimens result in increased killing and suppression of the accessory gene regulator system of Staphylococcus aureus. Antimicrob Agents Chemother 56:3712–3719
67. Bulitta JB, Okusanya OO, Forrest A, Bhavnani SM, Clark K, Still JG, Fernandes P, Ambrose PG (2013) Population pharmacokinetics of fusidic acid: rationale for front-loaded dosing regimens due to autoinhibition of clearance. Antimicrob Agents Chemother 57:498–507
68. Lodise TP, Patel N, Lomaestro BM, Rodvold KA, Drusano GL (2009) Relationship between initial vancomycin concentration–time profile and nephrotoxicity among hospitalized patients. Clin Infect Dis 49:507–514
69. Bhavnani SM, Rubino CM, Ambrose PG, Drusano GL (2010) Daptomycin exposure and the probability of elevations in the creatine phosphokinase level: data from a randomized trial of patients with bacteremia and endocarditis. Clin Infect Dis 50:1568–1574
70. Hanrahan TP, Harlow G, Hutchinson J, Dulhunty JM, Lipman J, Whitehouse T, Roberts JA (2014) Vancomycin-associated nephrotoxicity in the critically ill: a retrospective multivariate regression analysis. Crit Care Med 42:2527–2536
71. Boak LM, Rayner CR, Grayson ML, Paterson DL, Spelman D, Khumra S, Capitano B, Forrest A, Li J, Nation RL, Bulitta JB (2014) Clinical population pharmacokinetics and toxicodynamics of linezolid. Antimicrob Agents Chemother 58:2334–2343
72. Croes S, Koop AH, van Gils SA, Neef C (2012) Efficacy, nephrotoxicity and ototoxicity of aminoglycosides, mathematically modelled for modelling-supported therapeutic drug monitoring. Eur J Pharm Sci 45:90–100
73. Sasaki T, Takane H, Ogawa K, Isagawa S, Hirota T, Higuchi S, Horii T, Otsubo K, Ieiri I (2011) Population pharmacokinetic and pharmacodynamic analysis of linezolid and a hematologic side effect, thrombocytopenia, in Japanese patients. Antimicrob Agents Chemother 55:1867–1873
74. Bomela HN, Ballot DE, Cory BJ, Cooper PA (2000) Use of C-reactive protein to guide duration of empiric antibiotic therapy in suspected early neonatal sepsis. Pediatr Infect Dis J 19:531–535
75. Ramos-Martín V, Neely MN, McGowan P, Siner S, Padmore K, Peak M, Beresford MW, Turner MA, Paulus S, Hope WW (2016) Population pharmacokinetics and pharmacodynamics of teicoplanin in neonates: making better use of C-reactive protein to deliver individualized therapy. J Antimicrob Chemother 71:3168–3178