Status:
COMPLETED
Levofloxacin Pharmacokinetics (PK) in the Severely Obese
Lead Sponsor:
Joel Thompson, PhD
Collaborating Sponsors:
Ortho-McNeil Pharmaceutical
Conditions:
Obesity
Critical Illness
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 t...
Detailed Description
Although the pharmacokinetics of levofloxacin have been consistent in various study populations, obese and critically ill individuals are likely to demonstrate altered distribution and clearance of le...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00176306
Start Date
January 1 2005
End Date
June 1 2008
Last Update
June 6 2018
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536