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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01198925
Other study ID # 2010/414
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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