Clinical trial NCT01923363: PK/PD of High Dose Pip/Tazo in Obese Patients
Official title: Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: pharmacokinetics
obesity
piperacillin-tazobactam combination product
pharmacodynamics
piperacillin/tazobactam
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Serum Maximum Concentrations for Piperacillin
timeFrame: 0, 1, 3, and 6 hours post-dose
measure: Serum Minimum Concentrations of Piperacillin
timeFrame: 0, 1, 3, and 6 hours post-dose
Secondary outcomes:
measure: Half-life of Piperacillin
timeFrame: 0, 1, 3, and 6 hours post-dose
measure: Volume of Distribution of Piperacillin
timeFrame: 0, 1, 3, and 6 hours post-dose
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Steven C Forland, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.