SurgeryTAPASNCT03120663
Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients (TAPAS)
An observational study of Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- amoxicillin-clavulanic acid
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Nov 2016to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult non-critically ill surgery patient admitted at the abdominal, trauma or septic orthopaedic surgery wards from the University Hospitals Leuven
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Peter Declercq, PharmD., +321642340, peter.declercq@uzleuven.be
Peter Declercq, PharmD.
About this study
Official title: Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- amoxicillin-clavulanic acid
- Keywords
- antimicrobials, pharmacokinetics, augmented renal clearance, non critically ill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin-clavulanic acidDrug
Also called meropenem, flucloxacillin, piperacillin-tazobactam, clindamycin
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter the area under the plasma concentration versus time curve (AUC).
Measured: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Clearance (Cl)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter clearance (Cl).
Measured: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Volume of distribution (Vd)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter the volume of distribution (Vd).
Measured: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Half life (T1/2)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter the half life (T1/2).
Measured: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
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.
Measured: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start30 Nov 2016
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peter declercq, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Peter Declercq, PharmD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120663
- Sponsor's protocol ID
- S59726
- Acronym
- TAPAS
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients
- ClinicalTrials.gov ID
- NCT03120663
- Acronym / sponsor ID
- TAPAS / S59726
- Conditions
- Surgery
- Keywords
- antimicrobials, pharmacokinetics, augmented renal clearance, non critically ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult non-critically ill surgery patient admitted at the abdominal, trauma or septic orthopaedic surgery wards from the University Hospitals Leuven
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- age ≤ 18 years
- treatment restrictions corresponding to a Do Not Reanimate code
- pregnancy
- lactation
- renal replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin-clavulanic acidAlso: meropenem, flucloxacillin, piperacillin-tazobactam, clindamycinDuring 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 . | Drug | – |
Primary outcome
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
5 secondary outcomes
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.
Clearance (Cl)
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Volume of distribution (Vd)
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Half life (T1/2)
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Declercq, PharmD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Declercq, PharmD (003216342340, peter.declercq@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.