Urinary Bactericidal Activity of 4 Doses of Levofloxacin Against Fluoroquinolone-Resistant E. Coli

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

Single-dose studies of a fluoroquinolone are indicative of their antimicrobial activity since little accumulation occurs with multiple doses. Single-dose studies have been utilized to determine drug concentrations and time kill activity in serum, urine, and respiratory tissues. The purpose of this study is to evaluate the Urine Bactericidal Activity (UBA) of levofloxacin (250, 500, 750, and 1000 mg) against FQ-resistant, ESBL positive E. coli isolates. In addition, a susceptibility breakpoint concentration in the urine can also be established for each dose of levofloxacin. Furthermore, urine concentrations and serum pharmacokinetic parameters of levofloxacin can be determined.

Key facts

Study ID

NCT00376376

Run by

Michigan State University

People needed

10

Starts

2006-09-01

Expected to finish

2006-11-01

Last updated by the study team

2008-11-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy (from medical history) adult male or female volunteers
• Normal body weight (within 20 %)
• Age range: 18-60
• Not taking any other restricted medications (ie. antibiotics)

You may not qualify if…

• Non-healthy volunteers
• pregnant women
• volunteers on other antibiotics
• body weight over 20% of normal
• Age <18 or >60

Where it is running

• Michigan State University- Dept. of Medicine — East Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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