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

NCT01923363 | Completed Results DMC

• 1 other identifier: 5130259
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

pharmacokinetics; obesity; piperacillin-tazobactam combination product; pharmacodynamics; piperacillin/tazobactam

Outcome Measures

Primary Outcomes (2)

• Serum Maximum Concentrations for Piperacillin

  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

  Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses

  0, 1, 3, and 6 hours post-dose

Secondary Outcomes (2)

• Half-life of Piperacillin

  0, 1, 3, and 6 hours post-dose

• Volume of Distribution of Piperacillin

  0, 1, 3, and 6 hours post-dose

Study Arms (1)

Standard Dose to High Dose Piperacillin/Tazobactam

EXPERIMENTAL

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

Interventions

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.

Also known as: Zosyn

Standard Dose to High Dose Piperacillin/Tazobactam

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Location

Related Publications (1)

• Veillette JJ, Winans SA, Maskiewicz VK, Truong J, Jones RN, Forland SC. Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin-Tazobactam in Obese Patients. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):385-394. doi: 10.1007/s13318-021-00677-1. Epub 2021 Mar 20.

  PMID: 33743171 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Steven Forland
• Organization: Loma Linda University Medical Center

sforland@llu.edu

909-558-4000

Study Officials

• Steven C Forland, PharmD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist - Infectious Diseases

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 15, 2013
• Study Start: February 25, 2014
• Primary Completion: January 23, 2016
• Study Completion: January 23, 2016
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)