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

NCT03120663 | Unknown

• 1 other identifier: S59726
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

antimicrobials; pharmacokinetics; augmented renal clearance; non critically ill

Outcome Measures

Primary Outcomes (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

  Per antimicrobial of interest, we will determine the % of time that free concentrations are above minimal inhibitory concentrations (MIC) or antimicrobial EUCAST breakpoints

  During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.

Secondary Outcomes (5)

• Area under the plasma concentration versus time curve (AUC)

  During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.

• Clearance (Cl)

  During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.

• Volume of distribution (Vd)

  During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.

• Half life (T1/2)

  During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.

• Risk factors for target non attainment

  During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.

Interventions

amoxicillin-clavulanic acid DRUG

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 .

Also known as: meropenem, flucloxacillin, piperacillin-tazobactam, clindamycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

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.

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Meropenem; Floxacillin; Piperacillin, Tazobactam Drug Combination; Clindamycin

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Thienamycins; Carbapenems; Cloxacillin; Oxacillin; Tazobactam; Penicillanic Acid; Piperacillin; Sulfones; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Peter Declercq, PharmD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Declercq, PharmD

CONTACT

003216342340; peter.declercq@uzleuven.be

Isabel Spriet, PhD

CONTACT

003216341261; isabel.spriet@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 19, 2017
• Study Start: November 30, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)