Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00239161|
Recruitment Status : Terminated
First Posted : October 14, 2005
Last Update Posted : October 14, 2005
|Condition or disease||Intervention/treatment||Phase|
|Acute Uncomplicated Pyelonephritis||Drug: Levofloxacin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study|
|Study Start Date :||September 2004|
|Estimated Study Completion Date :||July 2005|
- Microbiological cure at the 10-14 day and 33-35 day followup
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239161
|St. Boniface General Hospital|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|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|