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

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Female

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 with infections of their kidney.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Janssen-Ortho Inc., Canada; Ortho-McNeil Pharmaceutical; PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Levofloxacin; Ofloxacin

Criteria

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.