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)
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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