Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections

Inclusion Criteria

• Males and females 18 to 90 years of age, inclusive.
• 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:

a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness;

OR

b. Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:

• Dysuria;
• Frequency;
• Suprapubic pain;
• Urgency

ii. At least one of the following complicating factors:

• Male gender;
• Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
• Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
• Urogenital surgery within 7 days preceding administration of the first dose of study drug;
• Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.

Exclusion Criteria

• Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
• Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed
• Complete, permanent obstruction of the urinary tract
• Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
• Suspected or confirmed perinephric or intrarenal abscess
• Suspected or confirmed prostatitis
• Known ileal loop or vesico-ureteral reflux
• Women who are pregnant or nursing