Levofloxacin Pharmacokinetics (PK) in the Severely Obese
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|ClinicalTrials.gov Identifier: NCT00176306|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : October 12, 2012
Last Update Posted : June 6, 2018
Obesity is known to affect the concentrations of certain medications in the body. Levofloxacin is a commonly used antibiotic. Based on what the investigators know about levofloxacin and how it moves through the body, obesity may affect levofloxacin concentrations. This study aims to show the effect of obesity on levofloxacin concentrations.
The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to severely obese, critically ill patients will yield serum concentrations that are likely to be therapeutic.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Critical Illness||Drug: Levofloxacin 750 mg IV||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Levofloxacin Pharmacokinetics in the Severely Obese|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Patients receiving levofloxacin 750mg IV
Drug: Levofloxacin 750 mg IV
PK in obesity
Other Name: Levaquin
- Plasma Concentration of Levofloxacin [ Time Frame: 24 hours ]A peripheral intravenous catheter will be placed in each arm for drug administration and serial blood sampling. Pre-existing intravenous access will be utilized when possible. Subjects will rest in a supine position while receiving a 750 mg intravenous dose of levofloxacin over 90 minutes. Serial blood samples will be obtained 1.5, 3, 4, 5, 8, 12, and 24 hours after the beginning of administration of levofloxacin. Data will be presented as mean area under the curve +/- standard deviation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176306
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Richard S Morehead, MD||University of Kentucky|