NCT00376376

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 27, 2008

Status Verified

November 1, 2008

First QC Date

September 13, 2006

Last Update Submit

November 25, 2008

Conditions

Healthy Volunteers

Keywords

levofloxacinpharmacodynamicbactericidal

Outcome Measures

Primary Outcomes (1)

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

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Non-healthy volunteers
  • pregnant women
  • volunteers on other antibiotics
  • body weight over 20% of normal
  • Age \<18 or \>60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University- Dept. of Medicine

East Lansing, Michigan, 48824, United States

Location

Study Officials

  • Gary E. Stein, Pharm.D.

    Michigan State University

    PRINCIPAL INVESTIGATOR

  • Daniel Havlichek, M.D.

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

September 1, 2006

Study Completion

November 1, 2006

Last Updated

November 27, 2008

Record last verified: 2008-11

Locations

US(1)