Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin

TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239161

Enrollment

Registered

2005-10-14

Start date

2004-09-30

Completion date

2005-07-31

Last updated

2005-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Uncomplicated Pyelonephritis

Keywords

Pyelonephritis

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.

Interventions

DRUGLevofloxacin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Microbiological cure at the 10-14 day and 33-35 day followup	—

Secondary

Measure	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.	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026