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Trial record 45 of 26588 for:    Anti-Infective Agents

Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients (TAPAS) (TAPAS)

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ClinicalTrials.gov Identifier: NCT03120663
Recruitment Status : Unknown
Verified April 2017 by peter declercq, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : April 19, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
peter declercq, Universitaire Ziekenhuizen Leuven

Brief Summary:

In this prospective observational study, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used antimicrobials in an adult non critically ill surgery population (abdominal surgery, traumatology and septic orthopedic surgery). Furthermore, the investigators want to identify risk factors for not attaining predefined PK/PD targets.

The antibiotics of interest are amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin.


Condition or disease Intervention/treatment
Surgery Drug: amoxicillin-clavulanic acid

Detailed Description:

In this research proposal, the primary objective is to describe PK parameters (area under the curve (AUC), clearance (Cl), distribution volume (Vd) and half life (T1/2)) for the antibiotics of interest (amoxicillin(-(clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin) for this adult non critically ill surgery population.

Besides, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used ABs in this population and to identify risk factors, for example augmented renal clearance (ARC), for not attaining predefined PK/PD targets.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Amoxicillin


Intervention Details:
  • Drug: amoxicillin-clavulanic acid

    During one dosing interval at steady state of the involved antimicrobials (ABs), AB plasma concentrations will be determined.

    Besides, the measured creatinine clearance based on an 8-hour urinary collection (CrCl8h) will be used as the primary method for determining kidney function. Based on these values, CrCl8h will be calculated according to the standard formula and normalized to a body surface area (BSA) of 1.73m² .

    Other Names:
    • meropenem
    • flucloxacillin
    • piperacillin-tazobactam
    • clindamycin


Primary Outcome Measures :
  1. The % of time that free concentrations of antimicrobials are above minimal inhibitory concentrations (MIC) or antimicrobial European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints [ Time Frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial. ]
    Per antimicrobial of interest, we will determine the % of time that free concentrations are above minimal inhibitory concentrations (MIC) or antimicrobial EUCAST breakpoints


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial. ]
    Per antimicrobial of interest, we will determine the pharmacokinetic parameter the area under the plasma concentration versus time curve (AUC).

  2. Clearance (Cl) [ Time Frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial. ]
    Per antimicrobial of interest, we will determine the pharmacokinetic parameter clearance (Cl).

  3. Volume of distribution (Vd) [ Time Frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial. ]
    Per antimicrobial of interest, we will determine the pharmacokinetic parameter the volume of distribution (Vd).

  4. Half life (T1/2) [ Time Frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial. ]
    Per antimicrobial of interest, we will determine the pharmacokinetic parameter the half life (T1/2).

  5. Risk factors for target non attainment [ Time Frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial. ]
    Multivariate analysis will be performed with target attainment as outcome. This will allow to identify risk factors for target non attainment.


Biospecimen Retention:   Samples Without DNA
Per patient, blood samples during 1 antimicrobial dosing interval and the measured creatinine clearance based on an 8-hour urinary collection (CrCl8h) will be collected.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult non-critically ill surgery patient admitted at the abdominal, trauma or septic orthopaedic surgery wards from the University Hospitals Leuven
Criteria

Inclusion Criteria:

Every adult non-critically ill surgery patient admitted at the abdominal, trauma or septic orthopaedic surgery wards from the University Hospitals Leuven treated with multiple doses of one of the antimicrobials of interest (i.e. intravenous (IV) amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem, oral or IV clindamycin) is eligible for inclusion.

Exclusion Criteria:

  • age ≤ 18 years
  • treatment restrictions corresponding to a Do Not Reanimate code
  • pregnancy
  • lactation
  • renal replacement therapy
  • planned discharge or surgery in the coming antimicrobial dosing interval making sampling impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120663


Contacts
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Contact: Peter Declercq, PharmD 003216342340 peter.declercq@uzleuven.be
Contact: Isabel Spriet, PhD 003216341261 isabel.spriet@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Peter Declercq, PharmD.    +321642340    peter.declercq@uzleuven.be   
Principal Investigator: Peter Declercq, PharmD.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Peter Declercq, PharmD Universitaire Ziekenhuizen Leuven

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Responsible Party: peter declercq, Principal investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03120663     History of Changes
Other Study ID Numbers: S59726
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by peter declercq, Universitaire Ziekenhuizen Leuven:
antimicrobials
pharmacokinetics
augmented renal clearance
non critically ill

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Piperacillin, Tazobactam Drug Combination
Anti-Infective Agents
Amoxicillin
Piperacillin
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors