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

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ClinicalTrials.gov Identifier: NCT01923363
Recruitment Status : Completed
First Posted : August 15, 2013
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Steven Forland, Loma Linda University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Piperacillin/Tazobactam Standard Dose to High Dose Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
Actual Study Start Date : February 25, 2014
Actual Primary Completion Date : January 23, 2016
Actual Study Completion Date : January 23, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Zosyn


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923363


Locations
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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Steven C Forland, PharmD Loma Linda University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven Forland, Clinical Pharmacy Specialist - Infectious Diseases, Loma Linda University
ClinicalTrials.gov Identifier: NCT01923363    
Other Study ID Numbers: 5130259
First Posted: August 15, 2013    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Steven Forland, Loma Linda University:
pharmacokinetics
obesity
piperacillin-tazobactam combination product
pharmacodynamics
piperacillin/tazobactam
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Tazobactam
Piperacillin
 Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action