Overview

Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion

Status:
Completed
Trial end date:
2018-05-03
Target enrollment:
0
Participant gender:
All
Summary
Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T > MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h). A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Ghent
Treatments:
Penicillanic Acid
Piperacillin
Piperacillin, tazobactam drug combination
Tazobactam
Criteria
Inclusion Criteria:

- Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical
surgery).

- Starting a treatment with piperacillin/tazobactam

- Signed informed consent

- Hematocrit >= 21%

- Available arterial line

Exclusion Criteria:

- age <18 or >75 years

- patient's weight <50 or >100 kg

- renal insufficiency (estimated clearance < 50 ML /MIN)

- haemodialysis

- WBC < 1000 103 µl

- estimated survival <5 days

- meningitis or other proven infections of the CNS

- IgE-mediated allergy to penicillins

- pregnancy

- patients having participated in another study <30 days before inclusion in the present
study

- retrospectively, marked deterioration of the renal function during the study period

- retrospectively, treatment < 96 h