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

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infections	Drug: Ceftaroline fosamil and NXL104 Drug: Doripenem Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Doripenem Ceftaroline Ceftaroline fosamil

U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC) [ Time Frame: 5 to 11 days after last dose of study drug ] [ Designated as safety issue: No ]
The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)
Evaluate safety [ Time Frame: from administration of first dose of study drug to the Late -Follow -Up (LFU) visit (28 to 42 days after administration of the last dose of study drug) ] [ Designated as safety issue: No ]
Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology and coagulation studies, comprehensive metabolic panel, and urinalysis), vital signs, ECGs, and physical examinations will be provided for each treatment group.

Secondary Outcome Measures:

Clinical response in CE at Test of Cure [ Time Frame: 5 to 11 days after last dose of study drug ] [ Designated as safety issue: No ]
The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC

Enrollment:	217
Study Start Date:	December 2010
Study Completion Date:	July 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ceftaroline fosamil and NXL104 (q8h)	Drug: Ceftaroline fosamil and NXL104 600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h); Other Name: Ceftaroline fosamil and NXL104 Drug: Placebo IV Placebo (saline) is administered to maintain the study blind Other Name: placebo
Experimental: Ceftaroline fosamil and NXL104 (q12h)	Drug: Ceftaroline fosamil and NXL104 600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h); Other Name: Ceftaroline fosamil and NXL104 (q12h) Drug: Placebo IV Placebo (saline) is administered to maintain the study blind Other Name: placebo
Active Comparator: Doripenem	Drug: Doripenem 500 mg doripenem IV q8h; Other Name: Doripenem Drug: Placebo IV Placebo (saline) is administered to maintain the study blind Other Name: placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281462

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Locations

United States, California
Investigational Site
La Mesa, California, United States, 91942
Investigational Site
San Diego, California, United States, 92120
United States, Florida
Investigational Site
Pensacola, Florida, United States, 32504
United States, Maryland
Investigational Site
Baltimore, Maryland, United States, 21287
United States, Michigan
Investigational Site
Detroit, Michigan, United States, 48202
Bulgaria
Investigational Site
Plovdiv, Bulgaria, 4002
Investigational Site
Ruse, Bulgaria, 7002
Investigational Site
Sofia, Bulgaria, 1606
Investigational Site
Sofia, Bulgaria, 1431
Investigational Site
Sofia, Bulgaria, 1407
Investigational Site
Varna, Bulgaria, 9002
Germany
Investigational Site
Berlin, Germany, 10117
Investigational Site
Freiburg, Germany, 79106
Investigational Site
Gießen, Germany, 35385
Investigational Site
Kassel, Germany, 34125
Investigational Site
Minden, Germany, 32429
Investigational Site
Muellheim, Germany, 79379
Investigational Site
Paderborn, Germany, 33098
Investigational Site
Planegg, Germany, 82152
Lebanon
Investigational Site
Beirut, Lebanon
Poland
Investigational Site
Bialystok, Poland, 15-950
Investigational Site
Bielsko-Biala, Poland, 43-316
Investigational Site
Częstochowa, Poland, 42-200
Investigational Site
Katowice, Poland, 40-073
Investigational Site
Katowice, Poland, 40-752
Investigational Site
Lodz, Poland, 90-153
Investigational Site
Tychy, Poland, 43-100
Investigational Site
Warszawa, Poland, 03-401
Investigational Site
Wolomin, Poland, 05-200
Investigational Site
Wrocław, Poland, 50-349
Investigational Site
Zamosc, Poland, 22-400
Russian Federation
Investigational Site
Moscow, Russian Federation, 105077
Investigational Site
Moscow, Russian Federation, 119992-119435
Investigational Site
Moscow, Russian Federation, 119049
Investigational Site
Moscow, Russian Federation, 105425
Investigational Site
Moscow, Russian Federation, 111123
Investigational Site
Rostov-on-Don, Russian Federation, 344022
Investigational Site
Smolensk, Russian Federation, 214018
Investigational Site
St. Petersburg, Russian Federation, 199178
Investigational Site
St. Petersburg, Russian Federation, 193312
Investigational Site
St. Petersburg, Russian Federation, 194044
Investigational Site
St. Petersburg, Russian Federation, 198205
Investigational Site
St. Petersburg, Russian Federation, 194354
Investigational Site
St. Petersburg, Russian Federation, 195067
Investigational Site
St. Petersburg, Russian Federation, 196247
Investigational Site
St. Petersburg, Russian Federation, 194291
Turkey
Investigational Site
Diyarbakir, Turkey, 21280
Investigational Site
Eskisehir, Turkey, 26480
Investigational Site
Izmir, Turkey, 35340
Investigational Site
Izmir, Turkey, 35040

Sponsors and Collaborators

Cerexa, Inc.

Investigators

Study Director:

Medical Monitor

Cerexa, Inc.

More Information

No publications provided

Responsible Party:	Cerexa, Inc.
ClinicalTrials.gov Identifier:	NCT01281462 History of Changes
Other Study ID Numbers:	CXL-MD-02
Study First Received:	January 13, 2011
Last Updated:	April 11, 2013
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Turkey: Ministry of Health Turkey: Ethics Committee Lebanon: Ministry of Public Health

Keywords provided by Cerexa, Inc.:

complicated Urinary Tract Infection
Acute Pyelonephritis

Additional relevant MeSH terms:

Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013