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| Sponsors and Collaborators: |
Michigan State University PriCara, Unit of Ortho-McNeil, Inc. |
|---|---|
| Information provided by: | Michigan State University |
| ClinicalTrials.gov Identifier: | NCT00376376 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Drug: levofloxacin at 250, 500, 750, and 1000 mg doses |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | Urinary Bactericidal Activity of 4 Doses of Levofloxacin (250, 500, &750, and 1000 mg) Against Fluoroquinolone-Resistant E. Coli |
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | November 2006 |
Subjects: -10 healthy (from medical history) adult male or female volunteers
Drug : all drugs are a single dose given after a 12 hour fast
Levofloxacin Pharmacokinetic Study:
A serum sample will be obtained prior to and at 1.5 (peak), 4.0, 8.0, 12 (50% of interval) and 24 (100% of interval) hours after each single dose of levofloxacin (6 time points).
Levels will be determined by an HPLC assay.
Urine Pharmacodynamic Study:
A urine sample will be obtained prior to and at 1.5 (peak), 4, 8, 12 (50% of interval), and 24 (100% of interval) hours after a single dose of each dose of levofloxacin.
A urine pH will be run on each sample.
All urine levels will be determined by a validated HPLC assay.
Study Isolates: E. coli (TRUST isolates):
Levofloxacin MICs:
This MIC range of E. coli isolates should be able to define a levofloxacin susceptibility breakpoint for urinary pathogens at each dose studied.
Urine Cidal Activity: Urine samples will be tested against each of the study isolates. A maximum urine cidal titer will be determined for each urine. The median titer at each time period (10 subjects) will determine the urine cidal activity.
The duration of cidal activity for each isolate will be determined and plotted. A 12-h duration will be considered the minimum time necessary for prolonged Urine Bactericidal Activity (MIC breakpoints).
Safety: All patients will be monitored for side effects during the study.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| Michigan State University- Dept. of Medicine | |
| East Lansing, Michigan, United States, 48824 | |
| Principal Investigator: | Gary E. Stein, Pharm.D. | Michigan State University |
| Principal Investigator: | Daniel Havlichek, M.D. | Michigan State University |
More Information
| Study ID Numbers: | MSU 06-496F |
| Study First Received: | September 13, 2006 |
| Last Updated: | November 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00376376 |
| Health Authority: | United States: Institutional Review Board |
|
levofloxacin pharmacodynamic bactericidal |
|
Fluoroquinolones Ofloxacin Healthy |
|
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |
