N/A
N=29
PK/PD of High Dose Pip/Tazo in Obese Patients
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01923363 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Oct 2018
Primary outcome: Primary: Serum Maximum Concentrations for Piperacillin — 136; 190; 237; 332 milligrams per liter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Piperacillin/Tazobactam Standard Dose to High Dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Maximum Concentrations for Piperacillin |
136; 190; 237; 332; 144; 214 | — |
| PRIMARY Serum Minimum Concentrations of Piperacillin |
8.9; 11.1; 27.0; 10.3; 47.4; 52.5 | — |
| SECONDARY Half-life of Piperacillin |
1.2; 1.5; 1.8; 0.9; 3.9; 2.7 | — |
| SECONDARY Volume of Distribution of Piperacillin |
19.0; 20.9; 27.7; 20.1; 31.6; 20.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01923363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.