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
  Purpose

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


Condition Intervention Phase
Bacterial Infections
Drug: IV Vancomycin plus IV Aztreonam
Drug: Ceftaroline
Phase 3

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
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

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 698
Study Start Date: February 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424190

  Show 52 Study Locations
Sponsors and Collaborators
Cerexa, Inc.
Investigators
Principal Investigator: Ralph Corey, MD Duke University
  More Information

No publications provided by Cerexa, Inc.

Additional 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 Publica 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

Keywords provided by Cerexa, Inc.:
Abscess
Antibacterial
Antibiotic
Antimicrobial
Bacterial infection, skin
Ceftaroline
Ceftaroline acetate
Cellulitis
Cephalosporin
Complicated skin and skin structure infection
cSSSI
Intravenous
MRSA
PPI-0903
Prodrug
Skin disease, bacterial
Skin infection
Staphylococcal skin infection
Staphylococcus aureus
Streptococcal skin infection
Surgical site infection
TAK-599

Additional relevant MeSH terms:
Bacterial Infections
Skin Diseases, Infectious
Infection
Skin Diseases
Aztreonam
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014