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

Anne-Grete Märtson; Marieke G G Sturkenboom; Jana Stojanova; Dario Cattaneo; William Hope; Deborah Marriott; Asad E Patanwala; Charles A Peloquin; Sebastian G Wicha; Tjip S van der Werf; Thomas Tängdén; Jason A Roberts; Michael N Neely; Jan-Willem C Alffenaar

doi:10.1016/j.cmi.2020.03.008

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

Anne-Grete Märtson, Marieke G G Sturkenboom, Jana Stojanova, Dario Cattaneo, William Hope, Deborah Marriott, Asad E Patanwala, Charles A Peloquin, Sebastian G Wicha, Tjip S van der Werf, Thomas Tängdén, Jason A Roberts, Michael N Neely, Jan-Willem C Alffenaar^*

^*Corresponding author for this work

Microbes in Health and Disease (MHD)

Research output: Contribution to journal › Review article › peer-review

38 Citations (Scopus)

64 Downloads (Pure)

Abstract

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. Implications: This is an overview of different aspects relevant for the conduct of a TDM study. We believe that this paper will help researchers and clinicians to design and conduct high-quality TDM studies.

Original language	English
Pages (from-to)	1008-1016
Number of pages	9
Journal	Clinical Microbiology and Infection
Volume	26
Issue number	8
Early online date	21-Mar-2020
DOIs	https://doi.org/10.1016/j.cmi.2020.03.008
Publication status	Published - Aug-2020

Keywords

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

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Märtson, A.-G., Sturkenboom, M. G. G., Stojanova, J., Cattaneo, D., Hope, W., Marriott, D., Patanwala, A. E., Peloquin, C. A., Wicha, S. G., van der Werf, T. S., Tängdén, T., Roberts, J. A., Neely, M. N., & Alffenaar, J.-W. C. (2020). How to design a study to evaluate therapeutic drug monitoring in infectious diseases? Clinical Microbiology and Infection, 26(8), 1008-1016. https://doi.org/10.1016/j.cmi.2020.03.008

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title = "How to design a study to evaluate therapeutic drug monitoring in infectious diseases?",

abstract = "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. Implications: This is an overview of different aspects relevant for the conduct of a TDM study. We believe that this paper will help researchers and clinicians to design and conduct high-quality TDM studies.",

keywords = "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",

author = "Anne-Grete M{\"a}rtson and Sturkenboom, {Marieke G G} and Jana Stojanova and Dario Cattaneo and William Hope and Deborah Marriott and Patanwala, {Asad E} and Peloquin, {Charles A} and Wicha, {Sebastian G} and {van der Werf}, {Tjip S} and Thomas T{\"a}ngd{\'e}n and Roberts, {Jason A} and Neely, {Michael N} and Alffenaar, {Jan-Willem C}",

year = "2020",

month = aug,

doi = "10.1016/j.cmi.2020.03.008",

language = "English",

volume = "26",

pages = "1008--1016",

journal = "Clinical Microbiology and Infection",

issn = "1198-743X",

publisher = "ELSEVIER SCI LTD",