Continuous infusion of beta-lactam antibiotics in severe sepsis: A multicenter double-blind, randomized controlled trial

Clinical Infectious Diseases

Volumn 56, Issue 2, 2013, Pages 236-244

  Dulhunty, Joel M ^a   Roberts, Jason A ^a   Davis, Joshua S ^b   Webb, Steven A R ^c   Bellomo, Rinaldo ^d   Gomersall, Charles ^e   Shirwadkar, Charudatt ^f   Eastwood, Glenn M ^d   Myburgh, John ^g   Paterson, David L ^h   Lipman, Jeffrey ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b MENZIES SCHOOL OF HEALTH RESEARCH   (Australia)

^c UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^d AUSTIN HOSPITAL   (Australia)

^e CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^f BLACKTOWN HOSPITAL   (Australia)

^g GEORGE INSTITUTE FOR GLOBAL HEALTH   (Australia)

^h UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

clinical outcome; meropenem; pharmacokinetics; piperacillin tazobactam; ticarcillin clavulanate

Indexed keywords

BETA LACTAM ANTIBIOTIC; MEROPENEM; PIPERACILLIN PLUS TAZOBACTAM; PLACEBO; TIMENTIN;

ADULT; AGED; ANTIBIOTIC THERAPY; ARTICLE; ASPIRATION PNEUMONIA; AUSTRALIA; BLOOD SAMPLING; CLINICAL ASSESSMENT; CONTINUOUS INFUSION; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; ENTEROCOCCUS; FEMALE; HONG KONG; HOSPITALIZATION; HUMAN; INTENSIVE CARE UNIT; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MULTICENTER STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SEPSIS; SEPTIC SHOCK; SURVIVAL RATE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; ANTI-BACTERIAL AGENTS; BETA-LACTAMS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; SEPSIS; TREATMENT OUTCOME;

EID: 84871758823     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cis856     Document Type: Article

References (38)

1. Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med 2004; 30:589-96. (Pubitemid 38530093)
2. Department of Infrastructure, Transport, Regional Development and Local Government. Road deaths Australia:2008 statistical summary, 2009. Available at: http://www.infrastructure.gov.au/roads/safety/publications/2009/rsr-04.aspx. Accessed 11 October 2012.
3. Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001; 29:1303-10. (Pubitemid 32641789)
4. Vincent JL, Rello J, Marshall J, et al. International study of the prevalence and outcomes of infection in intensive care units. JAMA 2009; 302:2323-9.
5. Martin CM, Priestap F, Fisher H, et al. A prospective, observational registry of patients with severe sepsis: the Canadian sepsis treatment and response registry. Crit Care Med 2009; 37:81-8.
6. Dellinger RP, Levy MM, Carlet JM, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock:2008. Intensive Care Med 2008; 34:17-60.
7. Dulhunty JM, Paterson DL, Webb SAR, Lipman J. Antimicrobial utilisation in 37 Australian and New Zealand intensive care units. Anaesth Intensive Care 2011; 39:231-7.
8. Lodise TP Jr, Lomaestro B, Drusano GL. Piperacillin-tazobactam for Pseudomonas aeruginosa infection: clinical implications of an extended-infusion dosing strategy. Clin Infect Dis 2007; 44:357-63. (Pubitemid 46147617)
9. McKinnon PS, Paladino JA, Schentag JJ. Evaluation of area under the inhibitory curve (AUIC) and time above the minimum inhibitory concentration (T>MIC) as predictors of outcome for cefepime and ceftazidime in serious bacterial infections. Int J Antimicrob Agents 2008; 31:345-51.
10. Roberts JA, Kruger P, Paterson DL, Lipman J. Antibiotic resistance-what's dosing got to do with it? Crit Care Med 2008; 36:2433-40.
11. Roberts JA, Webb S, Paterson D, Ho KM, Lipman J. A systematic review on clinical benefits of continuous administration of beta-lactam antibiotics. Crit Care Med 2009; 37:2071-8.
12. Roberts JA, Kirkpatrick CM, Roberts MS, Robertson TA, Dalley AJ, Lipman J. Meropenem dosing in critically ill patients with sepsis and without renal dysfunction: intermittent bolus versus continuous administration? Monte Carlo dosing simulations and subcutaneous tissue distribution. J Antimicrob Chemother 2009; 64:142-50.
13. Roberts JA, Paratz J, Paratz E, Krueger WA, Lipman J. Continuous infusion of beta-lactam antibiotics in severe infections: a review of its role. Int J Antimicrob Agents 2007; 30:11-8. (Pubitemid 46874893)
14. Kasiakou SK, Lawrence KR, Choulis N, Falagas ME. Continuous versus intermittent intravenous administration of antibacterials with time-dependent action: a systematic review of pharmacokinetic and pharmacodynamic parameters. Drugs 2005; 65:2499-511. (Pubitemid 41697317)
15. Kasiakou SK, Sermaides GJ, Michalopoulos A, Soteriades ES, Falagas ME. Continuous versus intermittent intravenous administration of antibiotics: a meta-analysis of randomised controlled trials. Lancet Infect Dis 2005; 5:581-9. (Pubitemid 41196757)
16. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of re-combinant human activated protein C for severe sepsis. N Engl J Med 2001; 344:699-709. (Pubitemid 32204987)
17. Viaene E, Chanteux H, Servais H, Mingeot-Leclercq MP, Tulkens PM. Comparative stability studies of antipseudomonal beta-lactams for potential administration through portable elastomeric pumps (home therapy for cystic fibrosis patients) and motor-operated syringes (intensive care units). Antimicrob Agents Chemother 2002; 46:2327-32. (Pubitemid 34793431)
18. Arlicot N, Rochefort GY, Schlecht D, Lamoureux F, Marchand S, Antier D. Stability of antibiotics in portable pumps used for bronchial superinfection: guidelines for prescribers. Pediatrics 2007; 120:1255-9. (Pubitemid 350223676)
19. Zhang Y, Trissel LA. Stability of piperacillin and ticarcillin in Auto-Dose infusion system bags. Ann Pharmacother 2001; 35:1360-3. (Pubitemid 33042066)
20. Smith DL, Bauer SM, Nicolau DP. Stability of meropenem in polyvi-nyl chloride bags and an elastomeric infusion device. Am J Health Syst Pharm 2004; 61:1682-5. (Pubitemid 39481378)
21. Patel PR, Cook SE. Stability of meropenem in intravenous solutions. Am J Health Syst Pharm 1997; 54:412-21. (Pubitemid 27089727)
22. McWhinney BC, Wallis SC, Hillister T, Roberts JA, Lipman J, Ungerer JP. Analysis of 12 beta-lactam antibiotics in human plasma by HPLC with ultraviolet detection. J Chromatogr B Analyt Technol Biomed Life Sci 2010; 878:2039-43.
23. US Department of Health and Human Services Food and Drug Administration, Centre for Drug Evaluation and Research, and Center for Veterinary Medicine. Guidance for industry: bioanalytical method validation, 2001. Available at: http://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/UCM070107.pdf. Accessed 11 October 2012.
24. MIMS Online (Australia). Full product information: Merrem IV, 2012. Available at: https://www.mimsonline.com.au. Accessed 11 October 2012.
25. MIMS Online (Australia). Full product information: Tazocin EF, 2012. Available at: https://www.mimsonline.com.au. Accessed 11 October 2012.
26. MIMS Online (Australia). Full product information: Timentin, 2012. Available at: https://www.mimsonline.com.au. Accessed 11 October 2012.
27. European Committee on Antimicrobial Susceptibility Testing. Breakpoint tables for interpretation of MICs and zone diameters, 2012. Available at: http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST-files/Disk-test-documents/ EUCAST-breakpoints-v-2.0-120101.pdf. Accessed 11 October 2012.
28. Roberts JA, Boots R, Rickard CM, et al. Is continuous infusion ceftri-axone better than once-a-day dosing in intensive care? A randomized controlled pilot study. J Antimicrob Chemother 2007; 59:285-91. (Pubitemid 47072068)
29. Vincent JL, Moreno R, Takala J, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. Intensive Care Med 1996; 22:707-10. (Pubitemid 26254283)
30. Kolahi J, Bang H, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol 2009; 37:477-84.
31. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials 2004; 25:143-56. (Pubitemid 38328755)
32. Nicolau DP, McNabb J, Lacy MK, Quintiliani R, Nightingale CH. Continuous versus intermittent administration of ceftazidime in intensive care unit patients with nosocomial pneumonia. Int J Antimicrob Agents 2001; 17:497-504. (Pubitemid 32492970)
33. Rafati MR, Rouini MR, Mojtahedzadeh M, et al. Clinical efficacy of continuous infusion of piperacillin compared with intermittent dosing in septic critically ill patients. Int J Antimicrob Agents 2006; 28:122-7. (Pubitemid 44108605)
34. Sakka SG, Glauner AK, Bulitta JB, et al. Population pharmacokinetics and pharmacodynamics of continuous versus short-term infusion of imipenem-cilastatin in critically ill patients in a randomized, controlled trial. Antimicrob Agents Chemother 2007; 51:3304-10. (Pubitemid 350067544)
35. Georges B, Conil JM, Cougot P, et al. Cefepime in critically ill patients: continuous infusion vs an intermittent dosing regimen. Int J Clin Pharmacol Ther 2005; 43:360-9. (Pubitemid 41078996)
36. Mouton JW, Vinks AA. Continuous infusion of beta-lactams. Curr Opin Crit Care 2007; 13:598-606. (Pubitemid 47357464)
37. Yost RJ, Cappelletty DM, group RS. The retrospective cohort of extended-infusion piperacillin-tazobactam (RECEIPT) study: a multi-center study. Pharmacotherapy 2011; 31:767-75.
38. McAuley DF, O'Kane C, Griffiths MJD. A stepwise approach to justify phase III randomized clinical trials and enhance the likelihood of a positive result. Crit Care Med 2010; 38:S523-27.