How to design a study to evaluate therapeutic drug monitoring in infectious diseases?

被引：37

作者：

Martson, A-G ^{[1
]}

Sturkenboom, M. G. G. ^{[1
]}

Stojanova, J. ^{[2
]}

Cattaneo, D. ^{[3
]}

Hope, W. ^{[4
,5
]}

Marriott, D. ^{[6
]}

Patanwala, A. E. ^{[7
,8
]}

Peloquin, C. A. ^{[9
]}

Wicha, S. G. ^{[10
]}

van der Werf, T. S. ^{[11
,12
]}

Tangden, T. ^{[13
]}

Roberts, J. A. ^{[14
,15
,16
,17
,18
]}

Neely, M. N. ^{[19
]}

Alffenaar, J-W C. ^{[1
,7
,20
,21
]}

机构：

[1] Univ Groningen, Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands

[2] Univ Valparaiso, Interdisciplinary Ctr Hlth Studies CIESAL, Valparaiso, Chile

[3] ASST Fatebenefratelli Sacco Univ Hosp, Dept Lab Med, Unit Clin Pharmacol, Milan, Italy

[4] Univ Liverpool, Antimicrobial Pharmacodynam & Therapeut, Liverpool, Merseyside, England

[5] Royal Liverpool Broadgreen Univ Hosp Trust, Liverpool, Merseyside, England

[6] St Vincents Hosp, Sydney, NSW, Australia

[7] Univ Sydney, Sydney Pharm Sch, Sydney, NSW, Australia

[8] Royal Prince Alfred Hosp, Sydney, NSW, Australia

[9] Univ Florida, Coll Pharm, Emerging Pathogens Inst, Infect Dis Pharmacokinet Lab, Gainesville, FL USA

[10] Univ Hamburg, Inst Pharm, Dept Clin Pharm, Hamburg, Germany

[11] Univ Groningen, Univ Med Ctr Groningen, Dept Pulm Dis & TB, Groningen, Netherlands

[12] Univ Groningen, Univ Med Ctr Groningen, Dept Internal Med, Groningen, Netherlands

[13] Uppsala Univ, Dept Med Sci, Uppsala, Sweden

[14] Univ Queensland, Fac Med, Ctr Clin Res, Brisbane, Qld, Australia

[15] Univ Queensland, Ctr Translat Antiinfect Pharmacodynam, Sch Pharm, Brisbane, Qld, Australia

[16] Royal Brisbane & Womens Hosp, Dept Pharm, Brisbane, Qld, Australia

[17] Royal Brisbane & Womens Hosp, Dept Intens Care Med, Brisbane, Qld, Australia

[18] Univ Montpellier, Nimes Univ Hosp, Div Anaesthesiol Crit Care Emergency & Pain Med, Nimes, France

[19] Childrens Hosp Los Angeles, Lab Appl Pharmacokinet & Bioinformat, Los Angeles, CA 90027 USA

[20] Westmead Hosp, Sydney, NSW, Australia

[21] Univ Sydney, Marie Bashir Inst Infect Dis & Biosecur, Sydney, NSW, Australia

来源：

CLINICAL MICROBIOLOGY AND INFECTION | 2020年 / 26卷 / 08期

基金：

澳大利亚国家健康与医学研究理事会;

关键词：

Drug exposure; Personalized dosing study design; Pharmacodynamics; Pharmacokinetics; Randomized controlled trials; Therapeutic drug monitoring; CRITICALLY-ILL PATIENTS; PROFICIENCY TESTING PROGRAM; QUASI-EXPERIMENTAL DESIGNS; BETA-LACTAM ANTIBIOTICS; EPITHELIAL LINING FLUID; QUALITY-CONTROL PROGRAM; POPULATION PHARMACOKINETICS; COST-EFFECTIVENESS; VANCOMYCIN; TUBERCULOSIS;

D O I：

10.1016/j.cmi.2020.03.008

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background: Therapeutic drug monitoring (TDM) is a tool to personalize and optimize dosing by measuring the drug concentration and subsequently adjusting the dose to reach a target concentration or exposure. The evidence to support TDM is however often ranked as expert opinion. Limitations in study design and sample size have hampered definitive conclusions of the potential added value of TDM. Objectives: We aim to give expert opinion and discuss the main points and limitations of available data from antibiotic TDM trials and emphasize key elements for consideration in design of future clinical studies to quantify the benefits of TDM. Sources: The sources were peer-reviewed publications, guidelines and expert opinions from the field of TDM. Content: This review focuses on key aspects of antimicrobial TDM study design: describing the rationale for a TDM study, assessing the exposure of a drug, assessing susceptibility of pathogens and selecting appropriate clinical endpoints. Moreover we provide guidance on appropriate study design. (C) 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

引用

页码：1008 / 1016

页数：9

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