Levofloxacin Pharmacokinetics (PK) in the Severely Obese - Full Text View

Sponsor:	University of Kentucky
Collaborators:	Ortho-McNeil Pharmaceutical National Institutes of Health (NIH)
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00176306

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:

The objective of this study is to determine if therapeutic concentrations are likely after giving a standard dose of levofloxacin to critically ill obese individuals

Secondary Outcome Measures:

Characterize pharmacokinetic parameters of levofloxacin in obese critically ill individuals: Cmax, Tmax, area under the concentration-time curve (AUC), volume of distribution, elimination rate, serum half-life, and urine clearance
Determine the percentage of patients that achieve an AUC/MIC ratio* of 88, which is achieved in 72% of non-obese, non-critically ill patients and is correlated with efficacy

Estimated Enrollment:	25
Study Start Date:	January 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 to 55 years of age
Body mass index > 35 kg/m2
Has been prescribed levofloxacin, but the medication has not yet been administered (hospitalized cohort only)

Exclusion Criteria:

Hypersensitivity to fluoroquinolones
Creatinine clearance < 50 ml/min
Administration of levofloxacin within the previous 7 days
Pregnant or lactating females
Participation in another investigational protocol within the past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176306

Locations

United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536

Sponsors and Collaborators

University of Kentucky

Ortho-McNeil Pharmaceutical

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Richard S Morehead, MD

University of Kentucky

More Information

No publications provided

Study ID Numbers:	CAPSS-391, CAPSS-391
Study First Received:	September 12, 2005
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00176306 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Anti-Infective Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Overweight
Renal Agents
Pharmacologic Actions

Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Pathologic Processes
Critical Illness
Therapeutic Uses
Nutrition Disorders
Overnutrition
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 05, 2009