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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281462
• Other study ID #: CXL-MD-02
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2011
• Last updated: January 2, 2014
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationTurkey: Ministry of HealthTurkey: Ethics CommitteeLebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Ceftaroline fosamil and NXL104 (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
• Ceftaroline fosamil and NXL104 (q12h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
• Doripenem
500 mg doripenem IV q8h;
• Placebo
On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.

Locations

Country	Name	City	State
Bulgaria	Investigational Site	Plovdiv
Bulgaria	Investigational Site	Ruse
Bulgaria	Investigational Site	Sofia
Bulgaria	Investigational Site	Sofia
Bulgaria	Investigational Site	Sofia
Bulgaria	Investigational Site	Varna
Germany	Investigational Site	Berlin
Germany	Investigational Site	Freiburg
Germany	Investigational Site	Gießen
Germany	Investigational Site	Kassel
Germany	Investigational Site	Minden
Germany	Investigational Site	Muellheim
Germany	Investigational Site	Paderborn
Germany	Investigational Site	Planegg
Lebanon	Investigational Site	Beirut
Poland	Investigational Site	Bialystok
Poland	Investigational Site	Bielsko-Biala
Poland	Investigational Site	Czestochowa
Poland	Investigational Site	Katowice
Poland	Investigational Site	Katowice
Poland	Investigational Site	Lodz
Poland	Investigational Site	Tychy
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Wolomin
Poland	Investigational Site	Wroclaw
Poland	Investigational Site	Zamosc
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Rostov-on-Don
Russian Federation	Investigational Site	Smolensk
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Turkey	Investigational Site	Diyarbakir
Turkey	Investigational Site	Eskisehir
Turkey	Investigational Site	Izmir
Turkey	Investigational Site	Izmir
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Detroit	Michigan
United States	Investigational Site	La Mesa	California
United States	Investigational Site	Pensacola	Florida
United States	Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  Lebanon,  Poland,  Russian Federation,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)	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)	5 to 11 days after last dose of study drug	No
Primary	Evaluate safety	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.	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)	No
Secondary	Clinical response in CE at Test of Cure	The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC	5 to 11 days after last dose of study drug	No