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| ID | Type | Description | Link |
|---|---|---|---|
| LOF-UTI-2 |
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| Name | Class |
|---|---|
| Ortho-McNeil Pharmaceutical | INDUSTRY |
| Janssen-Ortho Inc., Canada | INDUSTRY |
| PriCara, Unit of Ortho-McNeil, Inc. | INDUSTRY |
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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological cure at the 10-14 day and 33-35 day followup |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion Criteria:
·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada | ||
| Health Sciences Centre |
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| ID | Term |
|---|---|
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| Winnipeg |
| Manitoba |
| R3A 1R9 |
| Canada |
| Misericordia Urgent Care | Winnipeg | Manitoba | R3C 1A2 | Canada |
| University of Manitoba | Winnipeg | Manitoba | R3E 0W3 | Canada |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011702 | Pyelitis |
| D052801 | Male Urogenital Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |