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

Condition(s) targeted: Obesity

Intervention: Piperacillin/Tazobactam Standard Dose (Drug); Piperacillin/Tazobactam High Dose (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Loma Linda University

Official(s) and/or principal investigator(s):
Steven C Forland, PharmD, Principal Investigator, Affiliation: Loma Linda University

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Serum maximum concentrations for piperacillin and tazobactam

Serum minimum concentrations of piperacillin and tazobactam

Secondary outcome:

Number of patients with adverse effects

Half-life of piperacillin and tazobactam

Volume of distribution of both piperacillin and tazobactam

Clearance of both piperacillin and tazobactam

Area under the curve of both piperacillin and tazobactam

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

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

- Estimated creatinine clearance by Cockcroft-Gault of less than 50 mL/min

- 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

Loma Linda University Medical Center, Loma Linda, California 92350, United States; Recruiting
Steven C Forland, PharmD, Phone: 909-558-4000, Ext: 43980, Email: sforland@ahs.llumc.edu
Solomon A Winans, PharmD, Phone: 909-558-7587, Email: swinans@llu.edu
Steven C Forland, PharmD, Principal Investigator
Solomon A Winans, PharmD, Sub-Investigator
Victoria Maskiewicz, PhD, Sub-Investigator
Ingrid K Blomquist, MD, Sub-Investigator
David Bland, MBBS, Sub-Investigator

Starting date: January 2014
Last updated: October 8, 2014