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

Completed · Phase 2 · Has a placebo group

Conditions studied: Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT01281462

Run by

Forest Laboratories

People needed

217

Starts

2010-12-01

Expected to finish

2012-07-01

Last updated by the study team

2014-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Investigational Site — La Mesa, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — Pensacola, Florida, United States
• Investigational Site — Baltimore, Maryland, United States
• Investigational Site — Detroit, Michigan, United States
• Investigational Site — Plovdiv, Bulgaria
• Investigational Site — Rousse, Bulgaria
• Investigational Site — Sofia, Bulgaria
• Investigational Site — Sofia, Bulgaria
• Investigational Site — Sofia, Bulgaria
• Investigational Site — Varna, Bulgaria
• Investigational Site — Berlin, Germany
• Investigational Site — Freiburg im Breisgau, Germany
• Investigational Site — Giessen, Germany
• Investigational Site — Kassel, Germany
• Investigational Site — Minden, Germany
• Investigational Site — Müllheim, Germany
• Investigational Site — Paderborn, Germany
• Investigational Site — Planegg, Germany
• Investigational Site — Beirut, Lebanon
• Investigational Site — Bialystok, Poland
• Investigational Site — Bielsko-Biala, Poland
• Investigational Site — Częstochowa, Poland
• Investigational Site — Katowice, Poland
• Investigational Site — Katowice, Poland

Full record on ClinicalTrials.gov

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