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Completed

NCT Number: NCT01965340

Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission

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 Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure.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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult burn patients (≥ 18 years) admitted to the University Hospital of Lausanne during the study period receiving systemic anti-infectives agents for which TDM is available will be included.

Exclusion criteria

  • Patients not receiving systemic anti-infective agents therapy
  • Patients with length of hospital stay <72 hours
  • Patients refusing to give their written consent (or for which the therapeutic representative refuses) or incapable of understanding and lack of legal representative
  • Pregnant or breastfeeding women
  • Children <18 years

Treatment and study plan

Systematic Therapeutic Drug Monitoring for the intervention group

Other

Primary outcomes

  1. Time required to achieve anti-infective plasma concentrations in the target

    Time frame: Up to 3 years

  2. Numbers of concentrations within the target during an anti-infective agents course

    Time frame: Up to 3 years

Secondary outcomes

  1. Anti-infective agents consumption

    Time frame: Up to 3 years

  2. Development of antibiotic resistance

    Time frame: Up to 3 years

  3. Length of ICU stay based on TBSA

    Time frame: Up to 3 years

  4. Characterization of the pharmacokinetic profile of most widely used antibiotics

    Time frame: Up to 3 years

  5. Concentration - efficacy analysis

    Time frame: Up to 3 years

    Population pharmacokinetic (NONMEM software)

  6. Failure / resolution rate of infectious episodes

    Time frame: Up to 3 years

  7. Concentration - toxicity analysis

    Time frame: Up to 3 years

    Population pharmacokinetic (NONMEM software)

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2013
Registry last updated
Nov 11, 2016

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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