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

Surgery Clinical Trial

— TAPAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03120663
• Other study ID #: S59726
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 19, 2017
• Start date: November 30, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Peter Declercq, PharmD
• Phone: 003216342340
• Email: peter.declercq[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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 .

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Area under the plasma concentration versus time curve (AUC)	Per antimicrobial of interest, we will determine the pharmacokinetic parameter the 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.
Secondary	Clearance (Cl)	Per antimicrobial of interest, we will determine the pharmacokinetic parameter clearance (Cl).	During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Secondary	Volume of distribution (Vd)	Per antimicrobial of interest, we will determine the pharmacokinetic parameter the volume of distribution (Vd).	During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Secondary	Half life (T1/2)	Per antimicrobial of interest, we will determine the pharmacokinetic parameter the half life (T1/2).	During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Secondary	Risk factors for target non attainment	Multivariate analysis will be performed with target attainment as outcome. This will allow to identify risk factors for target non attainment.	During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.