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NCT Number: NCT00376376

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University- Dept. of Medicine

East Lansing, Michigan, 48824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. evaluate the Urine Bactericidal Activity (UBA) of different doses and urine levels of levofloxacin against drug-resistant bacteria.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • PriCara, Unit of Ortho-McNeil, Inc.

Registry information

Official study title

Urinary Bactericidal Activity of 4 Doses of Levofloxacin (250, 500, &750, and 1000 mg) Against Fluoroquinolone-Resistant E. Coli

Important dates

Study start
2006
Study completion
2006
First posted
Sep 14, 2006
Registry last updated
Nov 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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