Burn Clinical Trial
Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and
respiratory failure that used to be the major cause of mortality have progressively been
replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs
several weeks, or even months after injury as a consequence of sepsis usually caused by
multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with
topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn
trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR
bacteria.
Correct prescription of anti-infective agents could be one way to curb the steadily
increasing development of multidrug resistance. Administration of antibiotic to burn patient
is complex: they frequently suffer from kidney dysfunction, they usually experience
tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular
compartments, they often are hypo-albumin and protein-emic, and finally they present with a
profoundly modified metabolism. All those aspects make this particular population of
patients at high risk of both under or over prescription.
Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic
Drug Monitoring, has been introduced to clinical practice for several decades primarily to
avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the
increasing availability of detection techniques, the number of drugs that can be measured in
the plasma of patients has grown tremendously over the last decade. As a consequence, it is
currently possible to monitor drug concentrations not only to prevent toxicity, but also to
improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic
prescription in different populations of hospitalized patients, including critically ill
patients, with a direct impact on outcome.
Such studies amongst burn patients are however lacking, although this particular population
is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM
could improve antibiotic prescription in this peculiar population. To this end, we propose
to implement a 3-year prospective, randomized, mono-centric, clinical trial that will
analyze the impact of systematic TDM on anti-infective agent prescription amongst burned
patients.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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