Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin - Full Text View

Sponsors and Collaborators:	University of Manitoba Ortho-McNeil Pharmaceutical Janssen-Ortho Inc., Canada PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00239161

Purpose

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.

Condition	Intervention	Phase
Acute Uncomplicated Pyelonephritis	Drug: Levofloxacin	Phase IV

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	September 2004
Estimated Study Completion Date:	July 2005

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:

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239161

Locations

Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Misericordia Urgent Care
Winnipeg, Manitoba, Canada, R3C 1A2
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0W3

Sponsors and Collaborators

University of Manitoba

Ortho-McNeil Pharmaceutical

Janssen-Ortho Inc., Canada

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Principal Investigator:	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

More Information

No publications provided

Study ID Numbers:	CAPSS-353, LOF-UTI-2
Study First Received:	October 12, 2005
Last Updated:	October 12, 2005
ClinicalTrials.gov Identifier:	NCT00239161
Health Authority:	Canada: Health Canada

Keywords provided by University of Manitoba:

Pyelonephritis

Study placed in the following topic categories:

Urologic Diseases
Nephritis
Pyelonephritis
Ofloxacin
Kidney Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Nephritis, Interstitial
Therapeutic Uses
Anti-Infective Agents, Urinary

Enzyme Inhibitors
Renal Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Pyelitis

ClinicalTrials.gov processed this record on February 12, 2009