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High-Dose, Short-Course Levofloxacin for Complicated Urinary Tract Infections and Acute Pyelonephritis

Seth R. Strote, MD
Howard A. Klausner, MD
Henry Ford Hospital,
Department of Emergency Medicine,
Detroit, Michigan, USA

Urinary tract infections (UTIs) are common. They can be classified as either an infection of the lower tract, cystitis, or the upper tract, pyelonephritis. Pyelonephritis can be either acute or chronic. UTIs can be further classified as complicated or uncomplicated. Complicated urinary tract infections (cUTIs) are those associated with any co-morbid condition, such as obstruction, urologic dysfunction, multidrug-resistant pathogens, recent antibiotic usage, recent instrumentation, or affecting males in particular. Diagnosis is made by taking a history and physical examination, as well as a urinalysis and urine culture. Treatment is largely supportive and includes empiric antibiotics until urine culture and sensitivity data are available. Recently, antibiotic resistance in the therapy for both cUTI and acute pyelonephritis (AP) has increased, leading to new dosing regimens for existing antibiotics. This article reviews the use of high-dose, short-course levofloxacin for the treatment of cUTI and AP. A recent multicenter, randomized, double-blind controlled trial compared high-dose, short-course levofloxacin with standard dose ciprofloxacin for the treatment of cUTI and AP. In this study, subjects were randomized to either ciprofloxacin IV or PO 400/500 mg, twice daily for 10 days or levofloxacin 750 mg IV or PO once daily for 5 days. A total of 1,109 subjects were enrolled in the study and 619 of them had a confirmed diagnosis of cUTI or AP. A subgroup of the AP patients were examined in a separate study. In total, 506 subjects met the entry criteria and were included in the microbiologically evaluable (ME) population. At the end of therapy, the eradication rate for the modified intent-to-treat (mITT) population was 79.8% for the levofloxacin- and 77.5% for the ciprofloxacin-treated group (95% confidence interval [CI]: - 8.8-4.1). In the ME population eradication rates were 88.3% and 86.7% for the levofloxacin and ciprofloxacin populations, respectively (95% CI: - 7.4-4.2). In the subgroup with AP, microbiological eradication was 83% and 79.6% in the mITT population (95% CI: - 3.4-14.4) and 92.5% vs. 93.4% in the ME population (95% CI: - 7.1-8.9) for levofloxacin and ciprofloxacin, respectively. These studies demonstrated equal efficacy of the high-dose, short-course levofloxacin regimen compared with other antibiotics given in traditional regimens. Thus, high-dose, short-course levofloxacin provides a viable alternative to standard antibiotic therapy in cUTI and AP.

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