Pharmacokinetic variability and exposures of fluconazole, anidulafungin, and caspofungin in intensive care unit patients: Data from multinational Defining Antibiotic Levels in Intensive care unit (DALI) patients Study
详细信息 查看全文
- 作者：Mahipal G Sinnollareddy (1) (2) (3)
Jason A Roberts (1) (4)
Jeffrey Lipman (1) (4)
Murat Akova (5)
Matteo Bassetti (6)
Jan J De Waele (7)
Kirsi-Maija Kaukonen (8)
Despoina Koulenti (1) (9)
Claude Martin (10) (11)
Philippe Montravers (12)
Jordi Rello (13)
Andrew Rhodes (14)
Therese Starr (4)
Steven C Wallis (1)
George Dimopoulos (9)
on behalf of the DALI Study authors
1. Burns Trauma and Critical Care Research Centre ; The University of Queensland ; Brisbane ; Australia
2. School of Pharmacy and Medical Sciences ; University of South Australia ; Adelaide ; Australia
3. Therapeutics Research Centre ; Basil Hetzel Institute for Translational Health Research ; The Queen Elizabeth Hospital ; Adelaide ; Australia
4. Royal Brisbane and Women鈥檚 Hospital ; Brisbane ; Australia
5. School of Medicine ; Hacettepe University ; Ankara ; Turkey
6. Azienda Ospedaliera Universitaria Santa Maria della Misericordia ; Udine ; Italy
7. Ghent University Hospital ; Ghent ; Belgium
8. Helsinki University Central Hospital ; Helsinki ; Finland
9. Attikon University Hospital ; Athens ; Greece
10. Hospital Nord ; Marseille ; France
11. AzuRea Group ; Antibes ; France
12. Centre Hospitalier Universitaire Bichat-Claude Bernard ; AP-HP ; Universit茅 Paris VII ; Paris ; France
13. CIBERES ; Vall d鈥橦ebron Institute of Research ; Universitat Autonoma de Barcelona ; Barcelona ; Spain
14. St George鈥檚 Healthcare NHS Trust and St George鈥檚 University of London ; London ; England - 刊名：Critical Care
- 出版年：2015
- 出版时间：December 2015
- 年：2015
- 卷：19
- 期：1
- 全文大小：474 KB
- 参考文献：1. Eggimann P, Garbino J, Pittet D. Epidemiology of Candida species infections in critically ill non-immunosuppressed patients. Lancet Infect Dis. 2003;3:685鈥?02. CrossRef
2. Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, et al. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009;302:2323鈥?. 54" target="_blank" title="It opens in new window">CrossRef
3. Pfaller MA, Moet GJ, Messer SA, Jones RN, Castanheira M. Geographic variations in species distribution and echinocandin and azole antifungal resistance rates among Candida bloodstream infection isolates: report from the SENTRY Antimicrobial Surveillance Program (2008 to 2009). J Clin Microbiol. 2011;49:396鈥?. CrossRef
4. Holley A, Dulhunty J, Blot S, Lipman J, Lobo S, Dancer C, et al. Temporal trends, risk factors and outcomes in albicans and non-albicans candidaemia: an international epidemiological study in four multidisciplinary intensive care units. Int J Antimicrob Agents. 2009;33:554鈥?.
5. Dimopoulos G, Frantzeskaki F, Poulakou G, Armaganidis A. Invasive aspergillosis in the intensive care unit. Ann N Y Acad Sci. 2012;1272:31鈥?. 5.x" target="_blank" title="It opens in new window">CrossRef
6. Cornely OA, Bassetti M, Calandra T, Garbino J, Kullberg BJ, Lortholary O, et al. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: non-neutropenic adult patients. Clin Microbiol Infect. 2012;18 Suppl 7:19鈥?7. CrossRef
7. Pappas PG, Kauffman CA, Andes D, Benjamin Jr DK, Calandra TF, Edwards Jr JE, et al. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009;48:503鈥?5. 596757" target="_blank" title="It opens in new window">CrossRef
8. EUCAST. EUCAST technical note on fluconazole. Clin Microbiol Infect. 2008;14:193鈥?. CrossRef
9. Andes D, Diekema DJ, Pfaller MA, Bohrmuller J, Marchillo K, Lepak A. In vivo comparison of the pharmacodynamic targets for echinocandin drugs against Candida species. Antimicrob Agents Chemother. 2010;54:2497鈥?06. 584-09" target="_blank" title="It opens in new window">CrossRef
10. Zilberberg MD, Kollef MH, Arnold H, Labelle A, Micek ST, Kothari S, et al. Inappropriate empiric antifungal therapy for candidemia in the ICU and hospital resource utilization: a retrospective cohort study. BMC Infect Dis. 2009;10:150. 50" target="_blank" title="It opens in new window">CrossRef
11. Labelle AJ, Micek ST, Roubinian N, Kollef MH. Treatment-related risk factors for hospital mortality in Candida bloodstream infections. Crit Care Med. 2008;36:2967鈥?2. CrossRef
12. Andes D, Ambrose PG, Hammel JP, Van Wart SA, Iyer V, Reynolds DK, et al. Use of pharmacokinetic-pharmacodynamic analyses to optimize therapy with the systemic antifungal micafungin for invasive candidiasis or candidemia. Antimicrob Agents Chemother. 2011;55:2113鈥?1. CrossRef
13. Shah DN, Yau R, Lasco TM, Weston J, Salazar M, Palmer HR, et al. Impact of prior inappropriate fluconazole dosing on isolation of fluconazole-nonsusceptible Candida species in hospitalized patients with candidemia. Antimicrob Agents Chemother. 2012;56:3239鈥?3. CrossRef
14. Sinnollareddy M, Peake SL, Roberts MS, Lipman J, Roberts JA. Using pharmacokinetics and pharmacodynamics to optimise dosing of antifungal agents in critically ill patients: a systematic review. Int J Antimicrob Agents. 2012;39:1鈥?0. CrossRef
15. Roberts JA, Paul SK, Akova M, Bassetti M, De Waele JJ, Dimopoulos G, et al. DALI: defining antibiotic levels in intensive care unit patients: are current beta-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis. 2014;58:1072鈥?3. CrossRef
16. Roberts JA, De Waele JJ, Dimopoulos G, Koulenti D, Martin C, Montravers P, et al. DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic. BMC Infect Dis. 2012;12:152. 52" target="_blank" title="It opens in new window">CrossRef
17. FDA, Guidance for Industry: Bioanalytical Method Validation (2001). http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf [Last access 25 Sept 2013].
18. Sasongko L, Williams KM, Day RO, McLachlan AJ. Human subcutaneous tissue distribution of fluconazole: comparison of microdialysis and suction blister techniques. Br J Clin Pharmacol. 2003;56:551鈥?1. 5-2125.2003.01930.x" target="_blank" title="It opens in new window">CrossRef
19. Baddley JW, Patel M, Bhavnani SM, Moser SA, Andes DR. Association of fluconazole pharmacodynamics with mortality in patients with candidemia. Antimicrob Agents Chemother. 2008;52:3022鈥?. CrossRef
20. Clancy CJ, Yu VL, Morris AJ, Snydman DR, Nguyen MH. Fluconazole MIC and the fluconazole dose/MIC ratio correlate with therapeutic response among patients with candidemia. Antimicrob Agents Chemother. 2005;49:3171鈥?. 5" target="_blank" title="It opens in new window">CrossRef
21. Pai MP, Turpin RS, Garey KW. Association of fluconazole area under the concentration-time curve/MIC and dose/MIC ratios with mortality in nonneutropenic patients with candidemia. Antimicrob Agents Chemother. 2007;51:35鈥?. CrossRef
22. Rodriguez-Tudela JL, Almirante B, Rodriguez-Pardo D, Laguna F, Donnelly JP, Mouton JW, et al. Correlation of the MIC and dose/MIC ratio of fluconazole to the therapeutic response of patients with mucosal candidiasis and candidemia. Antimicrob Agents Chemother. 2007;51:3599鈥?04. CrossRef
23. Buijk SLCE, Gyssens IC, Mouton JW, Verbrugh HA, Touw DJ, Bruining HA. Pharmacokinetics of sequential intravenous and enteral fluconazole in critically ill surgical patients with invasive mycoses and compromised gastro-intestinal function. Intensive Care Med. 2001;27:115鈥?1. CrossRef
24. Sobue S, Tan K, Layton G, Eve M, Sanderson JB. Pharmacokinetics of fosfluconazole and fluconazole following multiple intravenous administration of fosfluconazole in healthy male volunteers. Br J Clin Pharmacol. 2004;58:20鈥?. 5-2125.2004.02107.x" target="_blank" title="It opens in new window">CrossRef
25. Liu P, Ruhnke M, Meersseman W, Paiva JA, Kantecki M, Damle B. Pharmacokinetics of anidulafungin in critically ill patients with candidemia/invasive candidiasis. Antimicrob Agents Chemother. 2013;57:1672鈥?. CrossRef
26. Wurthwein G, Cornely OA, Trame MN, Vehreschild JJ, Vehreschild MJ, Farowski F, et al. Population pharmacokinetics of escalating doses of caspofungin in a phase II study of patients with invasive aspergillosis. Antimicrob Agents Chemother. 2013;57:1664鈥?1. CrossRef
27. Stone JA, Holland SD, Wickersham PJ, Sterrett A, Schwartz M, Bonfiglio C, et al. Single- and multiple-dose pharmacokinetics of caspofungin in healthy men. Antimicrob Agents Chemother. 2002;46:739鈥?5. 5.2002" target="_blank" title="It opens in new window">CrossRef
28. Nguyen TH, Hoppe-Tichy T, Geiss HK, Rastall AC, Swoboda S, Schmidt J, et al. Factors influencing caspofungin plasma concentrations in patients of a surgical intensive care unit. J Antimicrob Chemother. 2007;60:100鈥?. 5" target="_blank" title="It opens in new window">CrossRef
29. Berl T, Wilner KD, Gardner M, Hansen RA, Farmer B, Baris BA, et al. Pharmacokinetics of fluconazole in renal failure. J Am Soc Nephrol. 1995;6:242鈥?.
30. Garey KW, Pai MP, Suda KJ, Turpin RS, Rege MD, Mingo DE, et al. Inadequacy of fluconazole dosing in patients with candidemia based on Infectious Diseases Society of America (IDSA) guidelines. Pharmacoepidemiol Drug Saf. 2007;16:919鈥?7. 5" target="_blank" title="It opens in new window">CrossRef
31. Voss A, de Pauw BE. High-dose fluconazole therapy in patients with severe fungal infections. Eur J Clin Microbiol Infect Dis. 1999;18:165鈥?4. 50252" target="_blank" title="It opens in new window">CrossRef - 刊物主题：Intensive / Critical Care Medicine; Emergency Medicine;
- 出版者：BioMed Central
- ISSN：1364-8535
文摘
Introduction The objective of the study was to describe the pharmacokinetics (PK) of fluconazole, anidulafungin, and caspofungin in critically ill patients and to compare with previously published data. We also sought to determine whether contemporary fluconazole doses achieved PK/pharmacodynamic (PD; PK/PD) targets in this cohort of intensive care unit patients. Methods The Defining Antibiotic Levels in Intensive care unit patients (DALI) study was a prospective, multicenter point-prevalence PK study. Sixty-eight intensive care units across Europe participated. Inclusion criteria were met by critically ill patients administered fluconazole (n鈥?鈥?5), anidulafungin (n鈥?鈥?), and caspofungin (n鈥?鈥?). Three blood samples (peak, mid-dose, and trough) were collected for PK/PD analysis. PK analysis was performed by using a noncompartmental approach. Results The mean age, weight, and Acute Physiology and Chronic Health Evaluation (APACHE) II scores of the included patients were 58聽years, 84聽kg, and 22, respectively. Fluconazole, caspofungin, and anidulafungin showed large interindividual variability in this study. In patients receiving fluconazole, 33% did not attain the PK/PD target, ratio of free drug area under the concentration-time curve from 0 to 24聽hours to minimum inhibitory concentration (fAUC0鈥?4/MIC) 鈮?00. The fluconazole dose, described in milligrams per kilogram, was found to be significantly associated with achievement of fAUC0鈥?4/MIC 鈮?00 (P鈥?鈥?.0003). Conclusions Considerable interindividual variability was observed for fluconazole, anidulafungin, and caspofungin. A large proportion of the patients (33%) receiving fluconazole did not attain the PK/PD target, which might be related to inadequate dosing. For anidulafungin and caspofungin, dose optimization also appears necessary to minimize variability.