CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Piperacillin/Tazobactam Standard Dose to High Dosedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01923363
NCT01923363N/ACompleted

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

Loma Linda University·interventional·Posted Aug 15, 2013·Updated Oct 26, 2018

In Brief

A clinical study evaluating Piperacillin/Tazobactam Standard Dose to High Dose for Obesity. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 15, 2013
Enrollment StartFeb 25, 2014
Primary CompletionJan 23, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.9 years ago

Interventions

Piperacillin/Tazobactam Standard Dose to High Dosedrug

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.