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

This study has been completed.
Sponsor:
Information provided by:
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00423657
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: ceftaroline
Drug: vancomycin plus aztreonam
Drug: Placebo
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 Ceftaroloine Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • Clinical Cure Rate at Test of Cure (TOC) (MITT Population) [ Time Frame: 8-15 days after last dose of study drug administration ] [ 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


  • The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the CE Populations. [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Evaluate the Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • To Evaluate the Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: last day of study drug administration ] [ Designated as safety issue: No ]
  • To Evaluate the 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 ]
  • To Evaluate Clnical 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 ]
  • To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21-35 days after last dose of study drug ] [ Designated as safety issue: Yes ]
  • To Evaluate Safety [ Time Frame: first study drug dose through TOC ] [ Designated as safety issue: Yes ]

Enrollment: 680
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftaroline fosamil for Injection
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Drug: ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Other Name: Experimental
Drug: Placebo
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Other Name: Placebo
Active Comparator: 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.
Drug: vancomycin plus 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:

Additonal purpose of this 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423657

  Show 54 Study Locations
Sponsors and Collaborators
Cerexa, Inc.
Investigators
Principal Investigator: Mark Wilcox, MD Old Medical School
  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: NCT00423657     History of Changes
Other Study ID Numbers: P903-07
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
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Austria: Ethikkommission
Austria: Federal Ministry for Health and Women
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
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
Latvia: State Agency of Medicines
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:
Infection
Communicable Diseases
Bacterial Infections
Vancomycin
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014