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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Avibactam; Ceftaroline fosamil; Cephalosporins; Doripenem

Criteria

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