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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00424190
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : November 7, 2010
Last Update Posted : March 14, 2017
Information provided by:
Forest Laboratories

Brief Summary:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: IV Vancomycin plus IV Aztreonam Drug: Ceftaroline Phase 3

Detailed Description:
Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 698 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection
Study Start Date : February 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Experimental: Ceftaroline for Injection Drug: Ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Other Name: Experimental

Active Comparator: IV Vancomycin and IV Aztreonam Drug: IV Vancomycin plus IV Aztreonam
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
Other Name: Active Comparator

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

    Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.

    Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.

    Indeterminate: Inability to determine an outcome

  2. 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 ]

Secondary Outcome Measures :
  1. Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ]
  2. Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: Last day of study drug administration ]
  3. Clinical and Microbiological Response by Pathogen at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ]
  4. Clinical Relapse at the Late Follow Up (LFU) Visit [ Time Frame: 21 to 35 days after the last dose of study drug ]
  5. Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21 to 35 days after the last dose of study drug ]
  6. Assess Safety [ Time Frame: First dose of study drug through TOC visit ]
    Comparisons of the number of participants with Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion Criteria:

  • Prior treatment of current cSSSI with an antimicrobial.
  • Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424190

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Sponsors and Collaborators
Forest Laboratories
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Principal Investigator: Ralph Corey, MD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Senior Vice President, Clinical Development, Cerexa, Inc
ClinicalTrials.gov Identifier: NCT00424190    
Other Study ID Numbers: P903-06
First Posted: January 18, 2007    Key Record Dates
Results First Posted: November 7, 2010
Last Update Posted: March 14, 2017
Last Verified: February 2017
Keywords provided by Forest Laboratories:
Bacterial infection, skin
Ceftaroline acetate
Complicated skin and skin structure infection
Methicillin-resistant Staphylococcus Aureus (MRSA)
Skin disease, bacterial
Skin infection
Staphylococcal skin infection
Staphylococcus aureus
Streptococcal skin infection
Surgical site infection
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents