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

NCT00239161 | Terminated Phase 4

• 2 other identifiers: CAPSS-353LOF-UTI-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Uncomplicated Pyelonephritis

Keywords

Pyelonephritis

Outcome Measures

Primary Outcomes (1)

• Microbiological cure at the 10-14 day and 33-35 day followup

Secondary Outcomes (1)

• 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.

Interventions

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Ortho-McNeil Pharmaceutical: collaborator
• Janssen-Ortho Inc., Canada: collaborator
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Study Sites (4)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Misericordia Urgent Care

Winnipeg, Manitoba, R3C 1A2, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 0W3, Canada

Location

MeSH Terms

Conditions

Pyelonephritis

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lindsay E Nicolle, MD, FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Godfrey KM Harding, MD, FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• George G Zhanel, PhD, FCCP

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 14, 2005
• Study Start: September 1, 2004
• Study Completion: July 1, 2005
• Last Updated: October 14, 2005

Record last verified: 2005-08

Locations

CA (4)