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Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin

NCT ID: NCT00239161

Last Updated: 2005-10-14

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-07-31

Brief Summary

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The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy to treat patients with infections of their kidney.

Detailed Description

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The goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. Specific study objectives include:

1. To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
2. To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
3. To identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.

Conditions

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Acute Uncomplicated Pyelonephritis

Keywords

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Pyelonephritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Levofloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recent onset (less than 7 days) of costovertebral angle pain or tenderness with or without fever, and with or without lower urinary tract symptoms (dysuria, frequency, urgency). Diabetic women without long term complications of diabetes (retinopathy, nephropathy, or neuropathy) may be enrolled.
* Stable hemodynamic status and able to tolerate oral medication.
* Pretherapy urine culture \>107 cfu/L (\>104 cfu/ml) of a uropathogen (E. coli, other Enterobacteriaceae, S. saprophyticus). Patients will be enrolled into the study prior to urine culture results being known. If pretherapy cultures are subsequently not positive (usually at 48 hours), subjects will be discontinued.
* Pyuria (\> 10 wbc/mm3 or \> 10 X106 wbc/L by hemocytometer; \> 6-10 wbc/hpf, or \> 1+ LE (leukocyte esterase) dipstick).

Exclusion Criteria

·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ortho-McNeil Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Janssen-Ortho Inc., Canada

INDUSTRY

Sponsor Role collaborator

PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Principal Investigators

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Lindsay E Nicolle, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Godfrey KM Harding, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

George G Zhanel, PhD, FCCP

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Misericordia Urgent Care

Winnipeg, Manitoba, Canada

Site Status

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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LOF-UTI-2

Identifier Type: -

Identifier Source: secondary_id

CAPSS-353

Identifier Type: -

Identifier Source: org_study_id