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OpenTrials
Completed

NCT Number: NCT01923363

PK/PD of High Dose Pip/Tazo 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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piperacillin/Tazobactam Standard Dose to High Dose

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2013
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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