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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings