Phase 4 N=15 Treatment

Levofloxacin Pharmacokinetics (PK) in the Severely Obese

Obesity · Critical Illness

Bottom Line

View on ClinicalTrials.gov: NCT00176306 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Plasma Concentration of Levofloxacin — 76 mg/L*hr

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levofloxacin 750 mg IV (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Joel Thompson, PhD
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Concentration of Levofloxacin	76	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00176306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.