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

10. november 2016 opdateret af: Anne Fournier, University of Lausanne Hospitals

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 Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure.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

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Vaud
      • Lausanne, Vaud, Schweiz, 1011
        • Centre Hospitalier Universitaire Vaudois

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients with systematic TDM of anti-infective agents
Patients with systematic TDM of anti-infective agents and dosages adapted accordingly
Ingen indgriben: Patients treated as usual

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time required to achieve anti-infective plasma concentrations in the target
Tidsramme: Up to 3 years
Up to 3 years
Numbers of concentrations within the target during an anti-infective agents course
Tidsramme: Up to 3 years
Up to 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anti-infective agents consumption
Tidsramme: Up to 3 years
Up to 3 years
Development of antibiotic resistance
Tidsramme: Up to 3 years
Up to 3 years
Length of ICU stay based on TBSA
Tidsramme: Up to 3 years
Up to 3 years
Characterization of the pharmacokinetic profile of most widely used antibiotics
Tidsramme: Up to 3 years
Up to 3 years
Concentration - efficacy analysis
Tidsramme: Up to 3 years
Population pharmacokinetic (NONMEM software)
Up to 3 years
Failure / resolution rate of infectious episodes
Tidsramme: Up to 3 years
Up to 3 years
Concentration - toxicity analysis
Tidsramme: Up to 3 years
Population pharmacokinetic (NONMEM software)
Up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

27. september 2013

Først indsendt, der opfyldte QC-kriterier

17. oktober 2013

Først opslået (Skøn)

18. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Protocol 195/13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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