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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
Sponsor:
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by (Responsible Party):
Joel Thompson, PhD, University of Kentucky

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levofloxacin
Patients receiving levofloxacin 750mg IV
Drug: Levofloxacin 750 mg IV
PK in obesity
Other Name: Levaquin




Primary Outcome Measures :
  1. 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.



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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

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
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Joel Thompson, PhD
Ortho-McNeil Pharmaceutical
Investigators
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Principal Investigator: Richard S Morehead, MD University of Kentucky

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Responsible Party: Joel Thompson, PhD, PhD, University of Kentucky
ClinicalTrials.gov Identifier: NCT00176306     History of Changes
Other Study ID Numbers: CAPSS-391
CAPSS-391 ( Other Identifier: Johnson & Johnson )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: October 12, 2012
Last Update Posted: June 6, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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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