PK/PD of High Dose Pip/Tazo in Obese Patients

October 25, 2018 updated by: Steven Forland, Loma Linda University

Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients

Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI greater than or equal to 30 kg/m2
  • Weight at least 105 kg
  • Age 18-89 years of age
  • Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
  • English or Spanish speaking
  • Central line access

Exclusion Criteria:

  • Do not meet specified inclusion criteria
  • Hepatic impairment classified by Child-Pugh Class B or greater
  • Documented pre-existing seizure disorder
  • Documented pre-existing hematologic disorder
  • Pregnancy
  • Documented allergy or contraindication to beta-lactams or tazobactam

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Dose to High Dose Piperacillin/Tazobactam
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Drug: Piperacillin/Tazobactam Standard Dose to High Dose
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Other Names:
  • Zosyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Maximum Concentrations for Piperacillin
Time Frame: 0, 1, 3, and 6 hours post-dose
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
0, 1, 3, and 6 hours post-dose
Serum Minimum Concentrations of Piperacillin
Time Frame: 0, 1, 3, and 6 hours post-dose
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses
0, 1, 3, and 6 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Half-life of Piperacillin
Time Frame: 0, 1, 3, and 6 hours post-dose
Half-life (t1/2) of piperacillin will be calculated from serum concentrations in both standard and high doses
0, 1, 3, and 6 hours post-dose
Volume of Distribution of Piperacillin
Time Frame: 0, 1, 3, and 6 hours post-dose
Volume of distribution (Vd) of piperacillin will be calculated from serum concentrations in both standard and high doses
0, 1, 3, and 6 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Steven C Forland, PharmD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2014

Primary Completion (Actual)

January 23, 2016

Study Completion (Actual)

January 23, 2016

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 15, 2013

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5130259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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