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Study Results
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Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia (CAP)
This study has been completed.
Study NCT00621504   Information provided by Cerexa, Inc.

First Received on February 11, 2008.   Last Updated on September 20, 2011   History of Changes
Results First Received: October 12, 2010  
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
Condition: Bacterial Pneumonia
Interventions: Drug: Ceftaroline fosamil for Injection
Drug: IV Ceftriaxone
Drug: Placebo
Drug: Clarithromycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The enrollment period was from 02 January 2008 to 29 December 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for up to 24 hours

Reporting Groups
  Description
Ceftaroline Fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
IV Ceftriaxone Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

Participant Flow:   Overall Study
    Ceftaroline Fosamil for Injection     IV Ceftriaxone  
STARTED     299     307  
COMPLETED     273     282  
NOT COMPLETED     26     25  
Adverse Event                 1                 3  
At the request of sponsor/investigator                 1                 0  
Withdrew consent                 9                 6  
Lost to Follow-up                 8                 10  
Other                 1                 0  
Death                 6                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Ceftaroline Fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
IV Ceftriaxone Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

Baseline Measures
    Ceftaroline Fosamil for Injection     IV Ceftriaxone     Total  
Number of Participants  
[units: participants]
 		  299     307     606  
Age  
[units: participants]
 		     
<65 years     154     157     311  
>= 65 years     145     150     295  
Age  
[units: years]
Mean ± Standard Deviation 		  61.0  ± 16.6     61.0  ± 16.6     61.0  ± 16.6  
Gender  
[units: participants]
 		     
Female     108     112     220  
Male     191     195     386  
Race/Ethnicity, Customized  
[units: participants]
 		     
Hispanic     29     27     56  
Non-Hispanic     270     280     550  



  Outcome Measures

1.  Primary:   Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations   [ Time Frame: 8 to 15 days after last dose of study drug ]
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2.  Primary:   Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population   [ Time Frame: 8-15 days after last dose of study drug ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Clinical Response at End of Therapy (EOT)   [ Time Frame: Last day of study drug administration ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Microbiological Success Rate at Test of Cure (TOC)   [ Time Frame: 8-15 days after last dose of study drug ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)   [ Time Frame: 8-15 days after last day of study drug ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Clinical and Microbiological Response by Pathogen at TOC   [ Time Frame: 8-15 days after last dose of study drug ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Clinical Relapse at Late Follow Up (LFU)   [ Time Frame: 21-35 days after last dose of study drug ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Microbiological Re-infection/Recurrence at LFU   [ Time Frame: 21 to 35 days after last dose of study drug ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Evaluate Safety   [ Time Frame: first dose, throughout the treatment period, and up to the TOC visit ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Clinical Sciences
Organization: Cerexa, Inc
phone: (510) 285-9200
e-mail: clinicaltrials@cerexa.com


No publications provided


Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT00621504     History of Changes
Other Study ID Numbers: P903-08
Study First Received: February 11, 2008
Results First Received: October 12, 2010
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board;   Hong Kong: Department of Health;   Hong Kong: Ethics Committee;   Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee;   Malaysia: Ministry of Health;   Thailand: Ethical Committee;   Thailand: Food and Drug Administration;   Thailand: Khon Kaen University Ethics Committee for Human Research;   Thailand: Ministry of Public Health;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Argentina: Human Research Bioethics Committee;   Brazil: Ministry of Health;   Brazil: National Committee of Ethics in Research;   Brazil: National Health Surveillance Agency;   Russia: Ethics Committee;   Russia: Ministry of Health and Social Development of the Russian Federation;   Russia: Pharmacological Committee, Ministry of Health;   Ukraine: Ministry of Health;   Ukraine: State Pharmacological Center - Ministry of Health;   Lithuania: Bioethics Committee;   Lithuania: State Medicine Control Agency - Ministry of Health;   Bulgaria: Bulgarian Drug Agency;   Bulgaria: Ministry of Health;   Romania: Ministry of Public Health;   Romania: National Medicines Agency





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