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Sponsors and Collaborators: |
University of Kentucky Ortho-McNeil Pharmaceutical National Institutes of Health (NIH) |
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Information provided by: | University of Kentucky |
ClinicalTrials.gov Identifier: | NCT00176306 |
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 | Intervention | Phase |
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Obesity Critical Illness |
Drug: Levofloxacin 750 mg IV |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Levofloxacin Pharmacokinetics in the Severely Obese |
Estimated Enrollment: | 25 |
Study Start Date: | January 2005 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aaron M Cook, PharmD | 859-323-9258 | amcook0@email.uky.edu |
United States, Kentucky | |
University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Aaron M Cook, PharmD 859-323-9258 amcook0@email.uky.edu | |
Principal Investigator: Richard S Morehead, MD | |
Sub-Investigator: Aaron M Cook, PharmD | |
Sub-Investigator: Craig A Martin, PharmD | |
Sub-Investigator: Val Adams, PharmD |
Principal Investigator: | Richard S Morehead, MD | University of Kentucky |
Study ID Numbers: | CAPSS-391, CAPSS-391 |
Study First Received: | September 12, 2005 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00176306 |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity Critical Illness |
Ofloxacin Nutrition Disorders Overweight Overnutrition |
Anti-Infective Agents Anti-Bacterial Agents Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |