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Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections (cSSSI)

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00424190
First received: January 16, 2007
Last updated: November 23, 2010
Last verified: November 2010
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 Infections
Interventions: Drug: IV Vancomycin plus IV Aztreonam
Drug: Ceftaroline

  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
Patients were recruited worldwide from February 2007 to November 2007

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 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
IV Vancomycin Plus IV Aztreonam Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours

Participant Flow:   Overall Study
    Ceftaroline Fosamil for Injection   IV Vancomycin Plus IV Aztreonam
STARTED   351   347 
COMPLETED   329   317 
NOT COMPLETED   22   30 
Withdrew consent                3                4 
Death                3                0 
Noncompliance                1                2 
Request of sponsor or investigator                0                2 
Diagnosis of osteomyelitis                0                1 
Other                15                21 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ceftaroline Fosamil for Injection Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
IV Vancomycin Plus IV Aztreonam Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Total Total of all reporting groups

Baseline Measures
   Ceftaroline Fosamil for Injection   IV Vancomycin Plus IV Aztreonam   Total 
Overall Participants Analyzed 
[Units: Participants]
 351   347   698 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.2  (17.17)   47.2  (17.01)   48.2  (17.10) 
Age, Customized 
[Units: Participants]
     
>=65 years   57   72   129 
<18 years   0   0   0 
>=18 years and < 65 years   294   275   569 
Gender 
[Units: Participants]
     
Female   131   129   260 
Male   220   218   438 
Race/Ethnicity, Customized 
[Units: Participants]
     
Non-Hispanic   268   270   538 
Hispanic   83   77   160 


  Outcome Measures

1.  Primary:   Clinical Cure Rate at Test of Cure (MITT Population)   [ Time Frame: 8-15 days after the end of treatment ]

2.  Primary:   Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population   [ Time Frame: 8-15 days after last dose of study drug ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Microbiological Success Rate at the TOC Visit   [ Time Frame: 8-15 days after last dose of study drug ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Clinical Response at the End of Therapy (EOT) Visit   [ Time Frame: Last day of study drug administration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

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

6.  Secondary:   Clinical Relapse at the Late Follow Up (LFU) Visit   [ Time Frame: 21 to 35 days after the last dose of study drug ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Microbiological Reinfection or Recurrence at the LFU Visit   [ Time Frame: 21 to 35 days after the last dose of study drug ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Assess Safety   [ Time Frame: First dose of study drug through TOC visit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Senior Vice President, Clinical Development, Cerexa, Inc
ClinicalTrials.gov Identifier: NCT00424190     History of Changes
Other Study ID Numbers: P903-06
Study First Received: January 16, 2007
Results First Received: October 12, 2010
Last Updated: November 23, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Italy: National Bioethics Committee
Italy: Ministry of Health
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Switzerland: Ethikkommission
Switzerland: Swissmedic
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health
Brazil: National Health Surveillance Agency
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Pública de Chile
Mexico: Ethics Committee
Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health