Loma Linda University Medical Center
Loma Linda, California, 92350, United States
NCT Number: NCT01923363
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.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
Loma Linda, California, 92350, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Zosyn
Time frame: 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.
Time frame: 0, 1, 3, and 6 hours post-dose
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses
Time frame: 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
Time frame: 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
Loma Linda University
Other
Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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