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

NCT01198925 | Completed Phase 4

• 1 other identifier: 2010/414
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Infectious Disease

Keywords

Infectious disease; piperacillin; continuous infusion; extended infusion

Outcome Measures

Primary Outcomes (1)

• pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion

  Determination of serum concentrations of piperacillin.

  6 hours

Secondary Outcomes (1)

• 95% probability of target attainment (PTA95) versus MIC of different organisms.

  96 hours

Study Arms (2)

extended infusion

ACTIVE COMPARATOR

Drug: piperacillin extended infusion

continuous infusion

EXPERIMENTAL

Drug: piperacillin continuous infusion

Interventions

piperacillin continuous infusion DRUG

piperacillin continuous infusion

continuous infusion

piperacillin extended infusion DRUG

piperacillin extended infusion

extended infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• retrospectively, marked deterioration of the renal function during the study period
• retrospectively, treatment \< 96 h

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent, Belgium

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johan Decruyenaere, MD, PhD

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: September 23, 2010
• Primary Completion: November 16, 2012
• Study Completion: May 3, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

BE (1)