Table 2.

Inclusion and Exclusion Criteria

Inclusion CriteriaExclusion Criteria
At least 105 colony-forming units of 1 or 2 uropathogensUncomplicated 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 hoursChronic 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
  • * Additional exclusion criteria added for this study.

  • UTI, urinary tract infection; WBC, white blood cell.