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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Michigan State University
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Fluoroquinolones; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Non-healthy volunteers

• pregnant women

• volunteers on other antibiotics

• body weight over 20% of normal

• Age <18 or >60