Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

This is an interventional treatment trial for Urinary Tract Infections focused on measuring complicated Urinary Tract Infection, Acute Pyelonephritis Read More

Inclusion Criteria:

Subjects must meet the following inclusion criteria:

• Have pyuria (white blood cells in the urine)
• Clinical signs and/or symptoms of cUTI (including acute pyelonephritis)
• Have a pretreatment baseline urine culture specimen
• The subject's infection would require initial treatment with IV antibiotics
• The subject must require initial hospitalization to manage the cUTI by the standard of care.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

• History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins, carbapenems)
• Confirmed fungal urinary tract infection
• Intractable UTI anticipated to require more than 10 days of study drug therapy
• Complete, permanent obstruction of the urinary tract\
• Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter that will not be removed during IV study drug administration
• Suspected or confirmed perinephric or intrarenal abscess
• Suspected or confirmed prostatitis
• Ileal loops or vesico-ureteral reflux
• Impairment of renal function including a calculated CrCl of < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria
• Renal transplantation
• Life expectancy less than 3 months
• Evidence of significant hepatic, hematological, or immunologic disease or dysfunction
• Past or current history of epilepsy or seizure disorder
• Women who are pregnant or nursing