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

Infectious Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198925
• Other study ID #: 2010/414
• Status: Completed
• Phase: Phase 4
• Start date: September 23, 2010
• Est. completion date: May 3, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 3, 2018
• Est. primary completion date: November 16, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• piperacillin continuous infusion
piperacillin continuous infusion
• piperacillin extended infusion
piperacillin extended infusion

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion	Determination of serum concentrations of piperacillin.	6 hours
Secondary	95% probability of target attainment (PTA95) versus MIC of different organisms.	Determination of the probability of target attainment versus MIC of different organisms.	96 hours

External Links

•   website University Hospital Ghent, Belgium