Levofloxacin Pharmacokinetics (PK) in the Severely Obese

Completed · Phase 4

Conditions studied: Obesity, Critical Illness

In brief

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.

Key facts

Study ID

NCT00176306

Run by

Joel Thompson, PhD

People needed

15

Starts

2005-01-01

Expected to finish

2008-06-01

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

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

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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