First published: 22 July 2026 | https://doi.org/10.1002/phar.70181
Erin F. Barreto, Erin K. McCreary, Rekha Pai Mangalore, Sonya Tang Girdwood, Rebecca Arriola, Cynthia Bens, Robert A. Bonomo, Andrea N. Edginton, Lisa T. Hong, Angela Huttner, Birgit C. P. Koch, Nicole Maranchick, Michael N. Neely, Charles R. Peloquin, Gauri G. Rao, Jason A. Roberts, Anka C. Röhr, Marc H. Scheetz, Audrey N. Schuetz, Paul R. Yarnold, Andres Zuluaga, Nathaniel J. Rhodes
This consensus guidance is endorsed by the European Society of Clinical Microbiology and Infectious Diseases, European Society of Clinical Microbiology and Infectious Diseases PK/PD of Anti-Infectives Study Group, Infectious Diseases Society of America, International Association of Therapeutic Drug Monitoring and Clinical Toxicology, Society of Critical Care Medicine, and the Society of Infectious Diseases Pharmacists
Abstract
Beta-lactam antibiotics (beta-lactams) are first-line treatments for most major infectious syndromes in acutely ill patients, with in vitro activity against common pathogens, demonstrated efficacy in trials, and a perceived low risk of adverse effects. The current dosing approach, informed by population-level data, tends to be simplistically reduced to a “one size fits all” dosing method which only accounts for body weight (i.e., in pediatrics) and end organ function to estimate drug clearance (e.g., estimated glomerular filtration rate); this approach results in substantial variability in observed serum concentrations in acutely ill patients, which can compromise real-world effectiveness and safety. Beta-lactam dose individualization, therefore, defined as a dosing regimen for one patient informed by measured concentrations from that patient, has been recommended in international clinical guidelines. Comprehensive guidance on best practices for beta-lactam dose individualization is lacking. To address this knowledge gap and develop guidance, a multidisciplinary panel of international experts was assembled from the disciplines of infectious diseases, critical care, pharmacometrics, and laboratory medicine, representing both adults and pediatrics. The panel systematically evaluated the literature, using the GRADE approach where feasible, to address broad thematic questions pertaining to whether beta-lactam dose individualization should be pursued, for what indications beta-lactam dose individualization is warranted, and the most critical considerations and best practices for implementation of beta-lactam individualization. The resultant consensus recommendations will equip healthcare professionals caring for acutely ill patients treated with beta-lactam therapy with the evidence and tools necessary to guide optimal use of beta-lactam dose individualization.
Beta-lactam antibiotics (beta-lactams) are first-line treatments for patients with infections and exhibit considerable pharmacokinetic/pharmacodynamic (PK/PD) variability in acutely ill patients which results in difficult to predict effectiveness and safety. Beta-lactam dose individualization, defined in this document as a dosing regimen for one patient informed by measured concentrations from that patient, may improve PK/PD target attainment and, in turn, clinical outcomes. Beta-lactam dose individualization is recommended in contemporary international clinical guidelines (e.g., for sepsis, pneumonia) to improve antibiotic effectiveness and safety. Comprehensive guidance on the key clinical, laboratory, and practical considerations for beta-lactam dose individualization is needed.
An international multidisciplinary panel of 19 experts was convened to provide consensus recommendations on the use of beta-lactam dose individualization in acutely ill patients. These recommendations are intended for healthcare professionals caring for hospitalized patients treated with beta-lactam therapy and those aiming to implement or optimize a beta-lactam dose individualization program. The most clinically important questions were identified and prioritized by the panel and grouped into three broad thematic questions: 1) What is the clinical impact of beta-lactam dose individualization? 2) What are the minimum requirements for successful beta-lactam dose individualization? 3) What are the technical and methodological considerations necessary to achieve beta-lactam dose individualization?
A systematic review of the literature was performed by a research librarian to identify all studies relevant to the key questions. When sufficient data were available, recommendations were informed by meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. An evidence-to-decision framework was applied to account for importance and frequency of the problem, values and preferences of those affected, certainty of the evidence, health benefits and harms, burden and balance, resource implications, equity, acceptability, and feasibility. In cases where the evidence was insufficient to qualify for GRADE assessment, best practice statements were developed based on consensus of the panelists. Consensus recommendations and best-practice statements were discussed and voted on by the panel and endorsed by international multidisciplinary professional organizations.
A summary of the questions, recommendations, and best practice statements is provided in the Table 1. A detailed characterization of the methods, literature evaluation, evidence summaries and rationales for each recommendation, and proposed future directions is available in the full text of this guidance.
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