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Open Access Highly Accessed Study protocol

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

Jason A Roberts12*, Jan J De Waele3, George Dimopoulos4, Despoina Koulenti4, Claude Martin5, Philippe Montravers6, Jordi Rello7, Andrew Rhodes8, Therese Starr2, Steven C Wallis1 and Jeffrey Lipman12

Author Affiliations

1 Burns Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Australia

2 Royal Brisbane and Women’s Hospital, Brisbane, Australia

3 Ghent University Hospital, Ghent, Belgium

4 Attikon University Hospital, Athens, Greece

5 Hospital Nord, Marseille, France

6 Centre Hospitalier Universitaire Bichat-Claude Bernard, AP-HP, Université Paris VII, Paris, France

7 Hospital Vall d’Hebron, Barcelona, Spain

8 St George’s Healthcare NHS Trust and St George’s University of London, London, England, UK

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BMC Infectious Diseases 2012, 12:152  doi:10.1186/1471-2334-12-152

Published: 6 July 2012

Abstract

Background

The clinical effects of varying pharmacokinetic exposures of antibiotics (antibacterials and antifungals) on outcome in infected critically ill patients are poorly described. A large-scale multi-centre study (DALI Study) is currently underway describing the clinical outcomes of patients achieving pre-defined antibiotic exposures. This report describes the protocol.

Methods

DALI will recruit over 500 patients administered a wide range of either beta-lactam or glycopeptide antibiotics or triazole or echinocandin antifungals in a pharmacokinetic point-prevalence study. It is anticipated that over 60 European intensive care units (ICUs) will participate. The primary aim will be to determine whether contemporary antibiotic dosing for critically ill patients achieves plasma concentrations associated with maximal activity. Secondary aims will compare antibiotic pharmacokinetic exposures with patient outcome and will describe the population pharmacokinetics of the antibiotics included. Various subgroup analyses will be conducted to determine patient groups that may be at risk of very low or very high concentrations of antibiotics.

Discussion

The DALI study should inform clinicians of the potential clinical advantages of achieving certain antibiotic pharmacokinetic exposures in infected critically ill patients.

Keywords:
Antibiotic; βeta-lactam; Glycopeptide; Triazole; Echinocandin; Continuous infusion; Extended infusion; Bolus dosing; Adverse events; Pharmacokinetics; Pharmacodynamics