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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01281462
First received: January 13, 2011
Last updated: January 2, 2014
Last verified: January 2014
  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 (q8h)
Drug: Ceftaroline fosamil and NXL104 (q12h)
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:


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 (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
Other Name: Ceftaroline fosamil and Avibactam(NXL104) (q8h)
Drug: 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.
Other Name: placebo (saline)
Experimental: Ceftaroline fosamil and NXL104 (q12h) Drug: Ceftaroline fosamil and NXL104 (q12h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
Other Name: Ceftaroline fosamil and Avibactam(NXL104) (q12h)
Drug: 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.
Other Name: placebo (saline)
Active Comparator: Doripenem Drug: Doripenem
500 mg doripenem IV q8h;
Other Name: Doripenem
Drug: 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.
Other Name: placebo (saline)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 50 Study Locations
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: January 2, 2014
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:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014