Inclusion and Exclusion Criteria
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| At least 105 colony-forming units of 1 or 2 uropathogens | Uncomplicated UTI |
| Acute pyelonephritis* | |
| One of the following: dysuria, increased urinary frequency, urgency, WBC >12,500/mm3 or ≥10% bands, temperature ≥100.4°F within the previous 24 hours | Chronic pyelonephritis |
| Complete obstruction | |
| Calculated creatinine clearance <50 mL/min | |
| Need for additional antimicrobial therapy for a coexisting infection or for the presenting UTI | |
| Need for or history of surgery or lithotripsy within 7 days of study entry | |
| Pathogen known to be resistant to the study medication | |
| Received >1 dose of any antibacterial for treatment of the UTI within 5 days of study entry (unless patient received at least 72 hours of a nonfluoroquinolone antibiotic and was deemed a clinical failure) | |
| Renal or perirenal abscess | |
| Acute or chronic bacterial prostatitis | |
| Epididymitis | |
| Pregnancy |
↵* Additional exclusion criteria added for this study.
UTI, urinary tract infection; WBC, white blood cell.