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

NCT ID: NCT00376376

Last Updated: 2008-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Subjects: -10 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)

Drug : all drugs are a single dose given after a 12 hour fast

* 1000 mg.levofloxacin
* 750 mg. levofloxacin
* 500 mg levofloxacin
* 250 mg levofloxacin

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:

* 0.125 (sensitive)
* 4.0 (intermediate)
* 8.0 (resistant)
* 16.0 (resistant)
* 32.0 (resistant)
* 64.0 (resistant)

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.

Conditions

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Healthy Volunteers

Keywords

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levofloxacin pharmacodynamic bactericidal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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levofloxacin at 250, 500, 750, and 1000 mg doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Principal Investigators

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Gary E. Stein, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Daniel Havlichek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Michigan State University- Dept. of Medicine

East Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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MSU 06-496F

Identifier Type: -

Identifier Source: org_study_id