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Status:

TERMINATED

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

Lead Sponsor:

University of Manitoba

Collaborating Sponsors:

Ortho-McNeil Pharmaceutical

Janssen-Ortho Inc., Canada

Conditions:

Acute Uncomplicated Pyelonephritis

Eligibility:

FEMALE

18-50 years

Phase:

PHASE4

Brief Summary

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 wi...

Detailed Description

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 th...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    July 1 2005

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00239161

    Start Date

    September 1 2004

    End Date

    July 1 2005

    Last Update

    October 14 2005

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    St. Boniface General Hospital

    Winnipeg, Manitoba, Canada, R2H 2A6

    2

    Health Sciences Centre

    Winnipeg, Manitoba, Canada, R3A 1R9

    3

    Misericordia Urgent Care

    Winnipeg, Manitoba, Canada, R3C 1A2

    4

    University of Manitoba

    Winnipeg, Manitoba, Canada, R3E 0W3