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

Information source: University of Manitoba
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Uncomplicated Pyelonephritis

Intervention: Levofloxacin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Manitoba

Official(s) and/or principal investigator(s):
Lindsay E Nicolle, MD, FRCPC, Principal Investigator, Affiliation: University of Manitoba
Godfrey KM Harding, MD, FRCPC, Principal Investigator, Affiliation: University of Manitoba
George G Zhanel, PhD, FCCP, Principal Investigator, Affiliation: University of Manitoba

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.

Clinical Details

Official title: TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Microbiological cure at the 10-14 day and 33-35 day followup

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Locations and Contacts

Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada

Misericordia Urgent Care, Winnipeg, Manitoba R3C 1A2, Canada

St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada

University of Manitoba, Winnipeg, Manitoba R3E 0W3, Canada

Additional Information

Starting date: September 2004
Last updated: October 12, 2005

Page last updated: August 23, 2015

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