Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Inclusion Criteria

• Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines).
• Be males or females ≥ 18 years of age
• If female, subject is non-lactating, and is either:
• Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
• Of childbearing potential and is practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse. Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication.
• Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication.
• Pyuria (white blood cell [WBC] count > 10/μL in unspun urine or ≥ 10 per high power field in spun urine).
• Clinical signs and/or symptoms of cUTI, either of:
• Pyelonephritis, as indicated by at least 2 of the following:
• Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
• Flank pain;
• Costovertebral angle tenderness or suprapubic tenderness on physical exam; or
• nausea or vomiting; OR
• Complicated lower UTI, as indicated by at least 2 of the following:
• At least 2 of the following new or worsening symptoms of cUTI:
• Dysuria; urinary frequency or urinary urgency;
• Documented fever (oral temperature > 38°C) accompanied by patient symptoms of rigors, chills, or "warmth";
• Suprapubic pain or flank pain;
• Costovertebral angle tenderness or suprapubic tenderness on physical exam; or
• Nausea or vomiting; plus,
• At least 1 of the following complicating factors:
• Males with documented history of urinary retention;
• Indwelling urinary catheter that is scheduled to be removed during IV study therapy and before the EOT;
• Current obstructive uropathy that is scheduled to be medically or surgically relieved during IV study therapy and before the EOT; or
• Any functional or anatomical abnormality of the urogenital tract (including anatomic malformations or neurogenic bladder) with voiding disturbance resulting in at least 100 mL residual urine.
• Have a pretreatment baseline urine culture specimen obtained within 24 hours before the start of administration of the first dose of study drug.

NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows the results of the baseline urine culture.

• Require IV antibacterial therapy for the treatment of the presumed cUTI.

Exclusion Criteria

• Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam or quinilone antibacterial (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
• Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., vancomycin, linezolid] are allowed.)
• Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
• Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an acti