NCT03738683

Brief Summary

Optimal understanding of piperacillin-tazobactam pharmacokinetics in critically ill patients is lacking resulting in large variation of achieved exposure and possible inadequate therapy. The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to individualize and optimize therapy for piperacillin-tazobactam and eventually improve outcome. In a multi-centre, observational, open-label study the investigators aim to define PK of free drug concentrations of both piperacillin and tazobactam in ICU patients and define a PK model for estimation of renal function that most accurately predicts piperacillin and tazobactam clearance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 21, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

October 22, 2018

Last Update Submit

November 20, 2019

Conditions

Bacterial Infections

Keywords

PharmacokineticsPiperacillin-tazobactamRenal functionIntensive Care UnitCystatin C

Outcome Measures

Primary Outcomes (1)

  • Total drug clearance

    Pharmacokinetic curves will be taken

    1 day

Secondary Outcomes (2)

  • Volume of distribution

    1 day

  • Area under the curve

    1 day

Interventions

Piperacillin/tazobactamDRUG

Dose according to summary of product characteristics (SPC) or local protocols

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All critically ill patients with a suspected or proven bacterial infection who are already treated with piperacillin-tazobactam as a part of routine clinical care are eligible for inclusion. A total of 40 patients will be included: 30 patients receiving intermittent infusion of piperacillin-tazobactam and 10 patients receiving continuous infusion.

You may qualify if:

  • Patient is admitted to an ICU.
  • Subject is at least 18 years old on the day of the first dosing.
  • Is managed with a central venous catheter or arterial line.
  • Patient is treated with piperacillin/tazobactam.

You may not qualify if:

  • Has previously participated in this trial.
  • Is on renal replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

  • Wallenburg E, Ter Heine R, Schouten JA, Raaijmakers J, Ten Oever J, Kolwijck E, Burger DM, Pickkers P, Frenzel T, Bruggemann RJM. An Integral Pharmacokinetic Analysis of Piperacillin and Tazobactam in Plasma and Urine in Critically Ill Patients. Clin Pharmacokinet. 2022 Jun;61(6):907-918. doi: 10.1007/s40262-022-01113-6. Epub 2022 Apr 4.

    PMID: 35377133DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples for determination of total and free drug concentrations of piperacillin and tazobactam and for determination of cystatin C. Urine for measuring 24h creatinine clearance

MeSH Terms

Conditions

Bacterial Infections

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 13, 2018

Study Start

February 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

November 21, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)