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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Piperacillin/Tazobactam Standard Dose to High Dose

• Registration Number: NCT01923363
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-15
• Study Start: 2014-02-25
• Primary Completion: 2016-01-23
• Study Completion: 2016-01-23
• Results First Submitted: 2018-04-27
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-25
• Last Update Submitted: 2018-10-25
• Results First Posted: 2018-10-26
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Dose to High Dose Piperacillin/Tazobactam	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. 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.

Primary Outcome Measures

Name	Time	Method
Serum Maximum Concentrations for Piperacillin	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.
Serum Minimum Concentrations of Piperacillin	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

Name	Time	Method
Half-life of Piperacillin	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
Volume of Distribution of Piperacillin	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

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States