PK/PD of High Dose Pip/Tazo in Obese Patients
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 10/28/2018 |
| Start Date: | February 25, 2014 |
| End Date: | January 23, 2016 |
Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
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.
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.
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
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