Clinical Trial: Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study
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 with infections of their kidney.
Detailed Summary:
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:
- To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
- To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
- 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.
Sponsor: University of Manitoba
Current Primary Outcome: Microbiological cure at the 10-14 day and 33-35 day followup
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical outcome at each visit. Microbiologic outcomes at 24,48,and72 hrs, adverse antimicrobial effects, adverse events or antimicrobial resistance. Correlation between pharmacodynamic parameters, bacteriologic and clinical resolution will be analyzed.
Original Secondary Outcome: Same as current
Information By: University of Manitoba
Dates:
Date Received: October 12, 2005
Date Started: September 2004
Date Completion: July 2005
Last Updated: October 12, 2005
Last Verified: August 2005
