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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01198925

Enrollment

Registered

2010-09-10

Start date

2010-09-23

Completion date

2018-05-03

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

Keywords

Infectious disease, piperacillin, continuous infusion, extended infusion

Brief 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

Interventions

DRUGpiperacillin continuous infusion

piperacillin continuous infusion

DRUGpiperacillin extended infusion

piperacillin extended infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion	6 hours	Determination of serum concentrations of piperacillin.

Secondary

Measure	Time frame	Description
95% probability of target attainment (PTA95) versus MIC of different organisms.	96 hours	Determination of the probability of target attainment versus MIC of different organisms.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026