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

Phase 4

Terminated

• Conditions: Acute Uncomplicated Pyelonephritis

• Registration Number: NCT00239161
• Lead Sponsor: University of Manitoba

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 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 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.

Study Timeline

• Study Start: 2004-09
• Study Completion: 2005-07
• Status Verified: 2005-08
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Last Update Submitted: 2005-10-12
• Study First Posted: 2005-10-14
• Last Update Posted: 2005-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Microbiological cure at the 10-14 day and 33-35 day followup

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Misericordia Urgent Care; 🇨🇦 Winnipeg, Manitoba, Canada

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada