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Sponsors and Collaborators: |
University of Manitoba Ortho-McNeil Pharmaceutical Janssen-Ortho Inc., Canada PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00239161 |
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 |
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Acute Uncomplicated Pyelonephritis |
Drug: Levofloxacin |
Phase IV |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | July 2005 |
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:
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion Criteria:
·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
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 |
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 |
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 |
Pyelonephritis |
Urologic Diseases Nephritis Pyelonephritis Ofloxacin Kidney Diseases |
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 |