Levofloxacin Pharmacokinetics (PK) in the Severely Obese

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Joel Thompson, PhD; University of Kentucky
• Collaborator: Ortho-McNeil Pharmaceutical
• Treatments: Levofloxacin; Ofloxacin

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