drugset
drugset / Trial / NCT00376376

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

NCT00376376 ↗

Completed 10 enrolled Michigan State University PriCara, Unit of Ortho-McNeil, Inc. · collab
Non-randomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2006-09
Primary completion
—
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Levofloxacin Small molecule 250 mg —
Subject Levofloxacin Small molecule 500 mg —
Subject Levofloxacin Small molecule 750 mg —
Subject Levofloxacin Small molecule 1000 mg —

Indications

No indication recorded.