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Levofloxacin Pharmacokinetics (PK) in the Severely Obese

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176306
First Posted: September 15, 2005
Last Update Posted: October 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by (Responsible Party):
Scott Morehead, University of Kentucky
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Levofloxacin Pharmacokinetics in the Severely Obese

Resource links provided by NLM:


Further study details as provided by Scott Morehead, University of Kentucky:

Primary Outcome Measures:
  • Area Under the Curve [ Time Frame: 24 hours ]
    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


Enrollment: 15
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levofloxacin
Patients receiving levofloxacin 750mg IV
Drug: Levofloxacin 750 mg IV
PK in obesity
Other Name: Levaquin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 to 55 years of age
  2. Body mass index > 35 kg/m2
  3. Has been prescribed levofloxacin, but the medication has not yet been administered (hospitalized cohort only)

Exclusion Criteria:

  1. Hypersensitivity to fluoroquinolones
  2. Creatinine clearance < 50 ml/min
  3. Administration of levofloxacin within the previous 7 days
  4. Pregnant or lactating females
  5. Participation in another investigational protocol within the past 30 days
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Ortho-McNeil Pharmaceutical
Investigators
Principal Investigator: Richard S Morehead, MD University of Kentucky
  More Information

Responsible Party: Scott Morehead, MD, University of Kentucky
ClinicalTrials.gov Identifier: NCT00176306     History of Changes
Other Study ID Numbers: CAPSS-391
CAPSS-391 ( Other Identifier: Johnson & Johnson )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: August 2, 2011
Results First Posted: October 12, 2012
Last Update Posted: October 12, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors