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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:
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00424190
First received: January 16, 2007
Last updated: November 23, 2010
Last verified: November 2010

January 16, 2007
November 23, 2010
February 2007
November 2007   (final data collection date for primary outcome measure)
  • Clinical Cure Rate at Test of Cure (MITT Population) [ Time Frame: 8-15 days after the end of treatment ] [ Designated as safety issue: No ]

    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 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

  • 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00424190 on ClinicalTrials.gov Archive Site
  • Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: Last day of study drug administration ] [ Designated as safety issue: No ]
  • Clinical and Microbiological Response by Pathogen at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical Relapse at the Late Follow Up (LFU) Visit [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Assess Safety [ Time Frame: First dose of study drug through TOC visit ] [ Designated as safety issue: No ]
    Comparisons of the number of participants with Adverse Events
Not Provided
Not Provided
Not Provided
 
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Infections
  • 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
  • Drug: Ceftaroline
    600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
    Other Name: Experimental
  • Experimental: Ceftaroline for Injection
    Intervention: Drug: Ceftaroline
  • Active Comparator: IV Vancomycin and IV Aztreonam
    Intervention: Drug: IV Vancomycin plus IV Aztreonam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
698
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Chile,   Germany,   Mexico,   Peru,   Poland,   Romania,   Russian Federation,   Ukraine
 
NCT00424190
P903-06
No
Senior Vice President, Clinical Development, Cerexa, Inc
Cerexa, Inc.
Not Provided
Principal Investigator: Ralph Corey, MD Duke University
Cerexa, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP