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- Klinische proef 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 Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure.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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Vaud
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Lausanne, Vaud, Zwitserland, 1011
- Centre Hospitalier Universitaire Vaudois
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Patients with systematic TDM of anti-infective agents
Patients with systematic TDM of anti-infective agents and dosages adapted accordingly
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Geen tussenkomst: Patients treated as usual
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Time required to achieve anti-infective plasma concentrations in the target
Tijdsspanne: Up to 3 years
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Up to 3 years
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Numbers of concentrations within the target during an anti-infective agents course
Tijdsspanne: Up to 3 years
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Up to 3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Anti-infective agents consumption
Tijdsspanne: Up to 3 years
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Up to 3 years
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Development of antibiotic resistance
Tijdsspanne: Up to 3 years
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Up to 3 years
|
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Length of ICU stay based on TBSA
Tijdsspanne: Up to 3 years
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Up to 3 years
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Characterization of the pharmacokinetic profile of most widely used antibiotics
Tijdsspanne: Up to 3 years
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Up to 3 years
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Concentration - efficacy analysis
Tijdsspanne: Up to 3 years
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Population pharmacokinetic (NONMEM software)
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Up to 3 years
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Failure / resolution rate of infectious episodes
Tijdsspanne: Up to 3 years
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Up to 3 years
|
|
Concentration - toxicity analysis
Tijdsspanne: Up to 3 years
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Population pharmacokinetic (NONMEM software)
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Up to 3 years
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Fournier A, Goutelle S, Que YA, Eggimann P, Pantet O, Sadeghipour F, Voirol P, Csajka C. Population Pharmacokinetic Study of Amoxicillin-Treated Burn Patients Hospitalized at a Swiss Tertiary-Care Center. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00505-18. doi: 10.1128/AAC.00505-18. Print 2018 Sep.
- Fournier A, Eggimann P, Pantet O, Pagani JL, Dupuis-Lozeron E, Pannatier A, Sadeghipour F, Voirol P, Que YA. Impact of Real-Time Therapeutic Drug Monitoring on the Prescription of Antibiotics in Burn Patients Requiring Admission to the Intensive Care Unit. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01818-17. doi: 10.1128/AAC.01818-17. Print 2018 Mar.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Protocol 195/13
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