CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Levofloxacin 750 mg IVdrug
Likely dose
Levofloxacin 750 mg IVAI-extracted
Key inclusion· 3
  • Age 18 to 55 years
  • Body mass index greater than 35 kg/m²
  • Prescribed levofloxacin but not yet administered (hospitalized patients only)
Key exclusion· 5
  • Hypersensitivity or allergy to fluoroquinolones
  • Creatinine clearance less than 50 mL/min
  • Levofloxacin administration within previous 7 days
  • Pregnant or lactating females

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00176306
NCT00176306Phase 4Completed

Levofloxacin Pharmacokinetics in the Severely Obese

Joel Thompson, PhD·interventional·Posted Sep 15, 2005·Updated Jun 6, 2018

In Brief

A Phase 4 clinical trial evaluating Levofloxacin 750 mg IV for Obesity and Critical Illness. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJan 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.8 years ago

Interventions

Levofloxacin 750 mg IVdrug

PK in obesity