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

January 2, 2014 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Investigational Site
      • Ruse, Bulgaria, 7002
        • Investigational Site
      • Sofia, Bulgaria, 1431
        • Investigational Site
      • Sofia, Bulgaria, 1606
        • Investigational Site
      • Sofia, Bulgaria, 1407
        • Investigational Site
      • Varna, Bulgaria, 9002
        • Investigational Site
  • Germany
      • 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
        • Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Investigational Site
  • Poland
      • 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
        • Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 111123
        • Investigational Site
      • Moscow, Russian Federation, 105077
        • Investigational Site
      • Moscow, Russian Federation, 105425
        • Investigational Site
      • Moscow, Russian Federation, 119049
        • Investigational Site
      • Moscow, Russian Federation, 119992-119435
        • Investigational Site
      • Rostov-on-Don, Russian Federation, 344022
        • Investigational Site
      • Smolensk, Russian Federation, 214018
        • Investigational Site
      • St. Petersburg, Russian Federation, 194291
        • Investigational Site
      • St. Petersburg, Russian Federation, 194354
        • Investigational Site
      • St. Petersburg, Russian Federation, 196247
        • Investigational Site
      • St. Petersburg, Russian Federation, 193312
        • Investigational Site
      • St. Petersburg, Russian Federation, 194044
        • Investigational Site
      • St. Petersburg, Russian Federation, 195067
        • Investigational Site
      • St. Petersburg, Russian Federation, 198205
        • Investigational Site
      • St. Petersburg, Russian Federation, 199178
        • Investigational Site
  • Turkey
      • Diyarbakir, Turkey, 21280
        • Investigational Site
      • Eskisehir, Turkey, 26480
        • Investigational Site
      • Izmir, Turkey, 35040
        • Investigational Site
      • Izmir, Turkey, 35340
        • Investigational Site
  • United States
    • California
      • La Mesa, California, United States, 91942
        • Investigational Site
      • San Diego, California, United States, 92120
        • Investigational Site
    • Florida
      • Pensacola, Florida, United States, 32504
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • placebo (saline)
EXPERIMENTAL: Ceftaroline fosamil and 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 Names:
  • placebo (saline)
Drug: Ceftaroline fosamil and NXL104 (q12h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
Other Names:
  • Ceftaroline fosamil and Avibactam(NXL104) (q12h)
ACTIVE_COMPARATOR: 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 Names:
  • placebo (saline)
Drug: Doripenem
500 mg doripenem IV q8h;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
Time Frame: 5 to 11 days after last dose of study drug
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
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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response in CE at Test of Cure
Time Frame: 5 to 11 days after last dose of study drug
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (ESTIMATE)

January 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-MD-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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