Clinical trial NCT00239161: Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin
Official title: TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Uncomplicated Pyelonephritis
Keywords: Pyelonephritis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Pharmaceutical
name: Janssen-Ortho Inc., Canada
name: PriCara, Unit of Ortho-McNeil, Inc.
First posted: 2005-10-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

1. To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
2. To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
3. 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 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.

Primary outcomes:
measure: Microbiological cure at the 10-14 day and 33-35 day followup
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Misericordia Urgent Care
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Lindsay E Nicolle, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Godfrey KM Harding, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: George G Zhanel, PhD, FCCP
role: PRINCIPAL_INVESTIGATOR
References: