Levofloxacin Pharmacokinetics (PK) in the Severely Obese

NCT00176306 | Completed Phase 4 Results

• 1 other identifier: CAPSS-391
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration of Levofloxacin

  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.

  24 hours

Study Arms (1)

Levofloxacin

EXPERIMENTAL

Patients receiving levofloxacin 750mg IV

Drug: Levofloxacin 750 mg IV

Interventions

Levofloxacin 750 mg IV DRUG

PK in obesity

Also known as: Levaquin

Levofloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Joel Thompson, PhD: lead
• Ortho-McNeil Pharmaceutical: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Obesity; Critical Illness

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The number of ambulatory volunteers was low The acutely ill cohort was a heterogeneous population We remain unable to predict the precise effect of all of these different physiologic processes on drug pharmacokinetics

Results Point of Contact

• Title: Aaron Cook
• Organization: University of Kentucky

amcook0@email.uky.edu

8593239258

Study Officials

• Richard S Morehead, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 6, 2018
• Results First Posted: October 12, 2012

Record last verified: 2018-05

Locations

US (1)